FDA Adverse Event
Other
Summary report: N
30432 DERMACEA X-RAY SPG 4X8 12 PLY
MDR report key: 1312141
·
Received February 11, 2009
Report
- Report Number
- 1282497-2009-00004
- Event Type
- Other
- Date Received
- February 11, 2009
- Date of Event
- July 1, 2008
- Report Date
- January 14, 2009
- Manufacturer
- WINNER INDUSTRIES
- Product Code
- GDY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMITTED 2/11/2009. AN INVESTIGATION IS UNDERWAY; UPON COMPLETION, THE RESULTS WILL FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN IN 2009 THAT A CUSTOMER HAD A PROBLEM WITH GAUZE SPONGE. THE CUSTOMER REPORTED THAT THE SPONGE IN PACK FRAYED AND LEFT BITS OF THE THREAD IN INCISION/WOUND. SURGEON HAD TO PLUCK BITS FROM INCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 30432 DERMACEA X-RAY SPG 4X8 12 PLY | X-RAY DETECTABLE SPONGE | GDY | WINNER INDUSTRIES | 441603 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |