MalfunctionGEC
TRAY WET SKIN SCRB/SM WING SPG
Received Feb 4, 2009
Report 9612030-2009-00001 · MDR key 1309861
Device
Product problems
- Detachment Of Device Component
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN IN 2009, THAT A CUSTOMER HAD AN ISSUE WITH A WET SKIN SCRUB KIT. THE CUSTOMER STATED THAT THE SPONGE USED TO PREP THE INSIDE OF THE VAGINA IS COMING OFF OF THE STICK.