FDA MAUDE data on complications with lasers, light sources,

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FDA MAUDE data on complications with lasers, light sources,

PostPosted by hopeful19 » Fri Aug 14, 2015 5:26 pm

Lasers Surg Med. 2015 Feb;47(2):133-40. doi: 10.1002/lsm.22328. Epub 2015 Feb 4.
FDA MAUDE data on complications with lasers, light sources, and energy-based devices.
Tremaine AM1, Avram MM.
Author information

Abstract
BACKGROUND AND OBJECTIVE:
It is essential for physicians to be fully informed regarding adverse events and malfunctions associated with medical devices that occur in routine practice. There is limited information on this important issue in the medical literature, and it is mostly based on initial studies and case reports. More advanced knowledge regarding device adverse events is necessary to guide physicians towards providing safe treatments. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected injuries from device use or malfunction. The database of MDRs, entitled Manufacturer and User Facility Device Experience (MAUDE) enables the FDA to monitor device performance and identify potential safety issues.
STUDY DESIGN/MATERIALS AND METHODS:
We employed the following search strategy to identify reported adverse events. We searched the MAUDE electronic database on the FDA website in December 2013: http://www.accessdata.fda.gov/scripts/c ... search.cfm We collected all reported cases between 1991 and December 2013. The search terms utilized included a comprehensive list of device manufacturers, specific product names, and the wavelengths/technology of the devices used in the field of dermatology.
RESULTS:
Our search yielded 1257 MDRs. Forty-five MDRs were excluded due to insufficient data. The data is broken down into the adverse events observed, such as, but not limited to: blistering, burns, scarring, dyschromia, fat loss, and nerve palsy. The MDRs describe the adverse event and attempt to determine if it was related to device malfunction versus operator error. Radiofrequency devices, diode lasers, and intense pulsed light devices were the most commonly reported devices related to injuries.
CONCLUSION:
1257 MDRs, from a myriad of devices used in dermatology, have been reported to the FDA as of December 2013. Despite the underreporting of adverse events, the MAUDE database is an untapped resource of post-market surveillance of medical devices. The database can offer additional information, which combined with the initial device studies and published case reports from our colleagues, will help raise awareness and improve patient safety.
© 2015 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.
KEYWORDS:
FDA; Nd:YAG; adverse events; alexandrite; cryolipolysis; diode; focused ultrasound; fractional resurfacing; intense pulsed light; laser hair removal; microwave technology; pulsed dye laser; radiofrequency
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