FDA Adverse Event
Malfunction
Summary report: N
VISTEC SPG 4X4 STR 10S 16 PLY
MDR report key: 2170806
·
Received June 22, 2011
Report
- Report Number
- 1018120-2011-00008
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Report Date
- June 22, 2011
- Manufacturer
- COVIDIEN
- Product Code
- GDY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH AN X-RAY DETECTABLE SPONGE. THE CUSTOMER REPORTS THE SPONGES ARE FRAYING ONCE THE SPONGE COLLECTS MOISTURE FROM THE WOUND. FORCEPS AND TWEEZERS ARE BEING USED TO REMOVE THE FRAYED GAUZE FROM THE WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISTEC SPG 4X4 STR 10S 16 PLY | X-RAY DETECTABLE SPONGE | GDY | COVIDIEN | 7317 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |