Failure to investigate complaints about devices that did not meet specifications and other serious quality system deviations landed Respire Medical Holdings an 11-item 483 following an FDA inspection of its Brooklyn, New York facility.
The company, which manufactures sleep apnea and dental devices, failed to evaluate complaints to determine if a medical device report should be submitted to the FDA, the agency said.
It received at least 19 complaints about its dental devices, ranging from the fixing element breaking off to patients waking up with screws under their lips. Some developed allergic reactions while others experienced burning of the mouth, and one patient possibly ingested part of the acrylic device.
The facility’s design validation didn’t ensure that devices conformed to defined user needs and intended uses. For example, the firm conducted a design change for its Respire Blue sleep apnea device, but the design plans didn’t describe or reference design and development activities or assign responsibility for implementing changes.
In addition, a technician was observed conducting a final release of one of the Respire Blue devices, documenting the measurements as “bite is good” and “fit is good.” The agency investigators noted that the technician didn’t measure the device using calipers or any other testing equipment.
Read the 483 here: www.fdanews.com/12-06-19-respiremedicalholdingsllc483.pdf.
Identifying Fraudulent Complaints
Trend data are only as good as the individual complaints providing the information. Not all complaints are equally valid. Some are, in fact, fraudulent. No company wants its customer service reps or other officials spending time on fraudulent complaints.
However, these may not always be easy to distinguish, especially at first; indicators of fraud can be subtle, warned Carol Kozlowski, manager of crisis management for insurance services at RQA. However, a carefully crafted complaint-handling system should include procedures to help identify any red flags for fraudulent complaints. Any red flags noted should be documented immediately.
Nonetheless, she recommended, companies should start from the assumption that a complaint is real. Each complaint should be handled the same, with escalation and investigation as warranted per the company’s complaint-handling SOPs. However, employees should always be on the alert for red flags, such as a complainant that:
Excerpted from the FDAnews management report: 6 Steps to Managing Drug and Device Customer Complaints.