FDA Adverse Event
Malfunction
Summary report: N
EXCILON
MDR report key: 2502184
·
Received March 16, 2012
Report
- Report Number
- 2502184
- Event Type
- Malfunction
- Date Received
- March 16, 2012
- Report Date
- March 16, 2012
- Manufacturer
- COVIDIEN
- Product Code
- EFQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
4X4 DRESSING SPONGES ARE PACKAGED IN PAPER WITH 6 PLY DRESSINGS 2/PACK. THE PAPER CANNOT BE PEELED BACK TO OPEN AND DROP SPONGES ON A STERILE FIELD WITHOUT CONTAMINATING THE SPONGES. THIS INVOLVES MULTIPLE LOTS.======================MANUFACTURER RESPONSE FOR 4X4 DRESSING SPONGES - EXCILON, KENDALL EXCILON DRESSING SPONGES 4X4 (PER SITE REPORTER).======================NO RESPONSE TO THIS REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXCILON | GAUZE/SPONGE | EFQ | COVIDIEN | * | 110003326462 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |