Fires in warehouse, devices trip Fluidotherapy maker.

Henley Healthcare, Sugarland, TX, Dallas District

Henley Healthcare of Sugarland, TX, had a difficult time coming up with documents to answer a 483 from the February/March 1999 inspection by Ellen Kleintop of the Dallas district.

According to the June 15 letter from the firm's director of regulatory affairs, Joyce Heinrich, a fire broke out in a warehouse and "all records and documents were boxed and sent to a restoration facility." Still, the maker of traction equipment and Fluidotherapy units felt the sting of a warning letter issued on Sept. 20 (Doc. 8186W) despite a 13-page response to the 483.

FDA also released a March 29, 1999, letter to the firm regarding labeling for several topical products it was making. However, no other documents released referred to the topicals at all.

Much of the 483 - the EIR was not released - covered various aspects of Henley's corrective and preventive actions (CAPA) and Medical Device Reporting (MDR) procedures.

Kleintop wrote that a complaint dated April 1997 involved "a fire incident in a model 115D Fluidotherapy device," and that Henley had not documented results of an investigation or a plan of corrective action. The 483 was annotated to indicate that the firm would correct this May 1.

In her June letter, Heinrich stated that the incident was "thoroughly investigated internally by knowledgeable individuals from manufacturing, engineering, quality assurance and regulatory affairs." Heinrich commented that Henley was unable to determine if a malfunction triggered the fire because "the unit was not returned in a timely fashion," but added that her firm issued a bulletin on preventive maintenance after this event.

The warning letter led with a citation, describing the situation as reportable as an MDR because "the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur." FDA referred back to this incident later in the warning letter, in the context of complaint files that did not include all events in connection with the various models of the Fluidotherapy unit.

Firm holds ground on MDRs

In her letter dated Oct. 19, 1999, Heinrich held her ground. She wrote that the firm had investigated the incident and referred to documentation of such. She commented further that she had enclosed documentation in support of Henley's decision not to report the incident as an MDR, mentioning the bulletin covering preventive maintenance of the device.

In a letter to the agency dated Dec. 8, Heinrich apparently ceded the point, writing that Henley had implemented a revised SOP for corrective action and MDR filing.

Later in 1999, another model of the Fluido-therapy device also became incendiary. Kleintop wrote that a complaint dated Nov. 26 "meets the MDR definition of a malfunction," but that Henley opted not to report the event to the agency.

Heinrich riposted by insisting that this was a one-time only event which Henley "investigated internally." She wrote that the incident was not formally written up outside of an engineering change notice (ECN) covering assembly of the model 110, but that the firm had issued a bulletin to all known purchasers of the models 110D/DE and that all units had been upgraded voluntarily. Heinrich insisted that since the event was an isolated one, "the decision was an appropriate one with no adverse consequences."

The warning letter noted a complaint dated Nov. 26 involving "a short-circuit and [a] spark/flame...which is believed to have been caused by long metal bolts that protruded into the inner housing, causing the housing to contact the electrical connectors for the heater."

The letter continued that a current of roughly 13 amps made its way from the connectors through the bolts, ending up running into the "aluminum legs of the device." As was the case for the April complaint, FDA's rationale was that the event was reportable because a recurrence could cause a serious injury or death.

Heinrich bulldogged this issue as well in her October letter. She insisted that, "as was discussed with the inspectors" during the audit, Henley had investigated the incident and concluded that "an MDR was not warranted." Nonetheless, Henley had "issued a service bulletin with an upgrade" to prevent recurrence of the short, according to Heinrich, and she noted further that FDA ordered a recall in July 1999.

Kleintop gathered materials for the agency's review while she was there and, according to the warning letter, CDRH reviewed labeling and promotional materials for the firm's products. The warning letter inquired as to the reason for not filing a 510(k) for the Fluidotherapy 115.

In her October letter, Heinrich insisted that the 115, which she stated had been introduced into commerce in the mid-1980s, was a "progression" of the 114, which Heinrich stated predated the "medical device regulations enactment date" in 1978. She commented that the 115 was not substantially different from the 114.

Heinrich also argued that a document FDA referenced in the warning letter, "When to submit a 510(k) for a Change to an Existing Device," came into being some eight to nine years after the 115 had been made commercially available, implying the guidance was not applicable.

Henley did not return calls for comment.

Henley Healthcare, Sugarland, TX, 2/24-3/19/99, Doc 108918M, $26.50 plus retrieval.