FDA Adverse Event
Malfunction
Summary report: N
VISTEC SPG 3-1/2X4 STR 10S 32 PLY
MDR report key: 1423891
·
Received March 31, 2009
Report
- Report Number
- 1018120-2009-00025
- Event Type
- Malfunction
- Date Received
- March 31, 2009
- Report Date
- March 19, 2009
- Manufacturer
- COVIDIEN
- Product Code
- GDY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON 03/19/2009, THAT A CUSTOMER HAD AN ISSUE WITH THE VISTEC SPONGE. THE CUSTOMER STATED THAT THE DRESSING FRAYED DURING USE IN SURGICAL SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISTEC SPG 3-1/2X4 STR 10S 32 PLY | GAUZE | GDY | COVIDIEN | 7320 | 90582701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |