FDA Adverse Event
Injury
Summary report: N
LMF
MDR report key: 2792485
·
Received October 4, 2012
Report
- Report Number
- 1213643-2012-00653
- Event Type
- Injury
- Date Received
- October 4, 2012
- Manufacturer
- DAVOL INC
- Product Code
- LMF
- PMA / PMN Number
- P80002
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS REC'D TO DATE. BASED ON THE INFO PROVIDED IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IT WAS REPORTED THAT AVITENE WAS PLACED IN THE PTS' HIP AND MINS AFTER THE PT HAD A SEVERE ANAPHYLACTIC REACTION. CURRENTLY, MEDICAL RECORDS HAVE NOT BEEN PROVIDED. A REVIEW OF THE MFG RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE OF A MFG RELATED CAUSE FOR THE REPORTED EVENT. ADDITIONALLY, ALLERGIC REACTION IS LISTED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTIONS FOR USE. IF ADD'L INFO IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LMF | LMF | DAVOL INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |