FDA Adverse Event
Other
Summary report: N
VISTEC SPG 4X4 STR 10S 16 PLY
MDR report key: 3918977
·
Received June 24, 2014
Report
- Report Number
- 1018120-2014-00011
- Event Type
- Other
- Date Received
- June 24, 2014
- Date of Event
- May 23, 2014
- Report Date
- May 28, 2014
- Manufacturer
- COVIDIEN
- Product Code
- GDY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A 4X4 SPONGE. THE CUSTOMER STATES THE RAYTECS WERE SHREDDING AND SMALL PIECES ABOUT 1/4 INCH WERE IN THE FIELD. THE CUSTOMER REPORTS THIS OCCURRED DURING AN OPEN VENTRAL HERNIA SURGERY. THE RAYTECS WERE REMOVED WITH FORCEPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367577 | VISTEC SPG 4X4 STR 10S 16 PLY | 4X4 SPONGE | GDY | COVIDIEN | 7317 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |