FDA Adverse Event
Injury
Summary report: N
LACTOSORB PECTUS STABILIZER
MDR report key: 2821920
·
Received November 7, 2012
Report
- Report Number
- 0001032347-2012-00159
- Event Type
- Injury
- Date Received
- November 7, 2012
- Report Date
- October 16, 2012
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- HRS
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
THE DISTRIBUTOR NOTIFIED OF A REVISION SURGERY THAT TOOK PLACE IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LACTOSORB PECTUS STABILIZER | PECTUS STABILIZER | HRS | BIOMET MICROFIXATION | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |