FDA Adverse Event
Other
Summary report: N
DERM X-RAY SPG 4X4 16 PLY ALT
MDR report key: 3736643
·
Received April 2, 2014
Report
- Report Number
- 1282497-2014-00020
- Event Type
- Other
- Date Received
- April 2, 2014
- Report Date
- March 19, 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 A X-RAY SPONGE. THE CUSTOMER REPORTS THAT THE X-RAY GAUZE LEFT LINT PIECES IN THE WOUND THAT HAD TO BE EXTRACTED. THE PROCEDURE WAS A HERNIA PEDIATRIC PACK. THERE WAS NO INJURY REPORTED. THE PIECES WERE EASILY EXTRACTED BY HAND IMMEDIATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200098 | DERM X-RAY SPG 4X4 16 PLY ALT | X-RAY SPONGE | GDY | ALLMED MEDICAL PRODUCTS | 441601A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |