MalfunctionFMP
GEL-E DONUT - MEDIUM
Received Sep 24, 2014
Report 1218950-2014-07316 · MDR key 4309749
Device
Generic name
Protector, Skin Pressure
Manufacturer
Philips RespironicsModel number
92025-CLot number
05/25/2015
Product problems
- Material Integrity Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THERE IS A MOLD ON THE DONUT. THERE WAS NO REPORTED PT INCIDENT/INJURY.
Additional Manufacturer Narrative
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.