FDA Adverse Event
Other
Summary report: N
DERM X-RAY SPG 4X4 16 PLY ALT
MDR report key: 3817503
·
Received May 5, 2014
Report
- Report Number
- 1282497-2014-00035
- Event Type
- Other
- Date Received
- May 5, 2014
- Report Date
- May 1, 2014
- Manufacturer
- ALLMED MEDICAL PRODUCTS
- 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 AN X-RAY SPONGE. THE CUSTOMER STATES THAT PIECES OF THE RAYTEC SPONGES IN THE LAPAROTOMY PACKS ARE FALLING INTO THE WOUNDS. THE CUSTOMER REPORTS DURING THE CASE, THE SURGEON NOTICED PIECES OF THE RAYTEC IN THE INCISION. THEY REMOVED THEM BY HAND AND STARTED USING THE LAP SPONGE. THE PROCEDURE WAS A HERNIA REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 266172 | DERM X-RAY SPG 4X4 16 PLY ALT | X-RAY SPONGE | GDY | ALLMED MEDICAL PRODUCTS | 441601A | 13259A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |