FDA Adverse Event
Malfunction
Summary report: N
SPONGE 300509 MEROCEL 100PK 2.5 X 5.1CM
MDR report key: 3895292
·
Received June 25, 2014
Report
- Report Number
- 1219071-2014-00002
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Date of Event
- May 12, 2014
- Report Date
- May 29, 2014
- Manufacturer
- XOMED MFG MYSTIC
- Product Code
- GDY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4) METHOD: NO TESTING METHODS PERFORMED (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON REMOVAL OF THE SURGICAL POST-OPERATIVE PACKING STRIP THE RADIOPEG PULLED OUT AND THE MATERIAL FRAGMENTED. THE FRAGMENTED PIECES WERE IRRIGATED AND REMOVED COMPLETELY FROM THE SITE. THERE WAS NO INJURY REPORTED AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371163 | SPONGE 300509 MEROCEL 100PK 2.5 X 5.1CM | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE | GDY | XOMED MFG MYSTIC | 300509 | 00020215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |