FDA Adverse Event
Injury
Summary report: N
ORTHADAPT BIOIMPLANT
MDR report key: 1522250
·
Received November 2, 2009
Report
- Report Number
- 3005147058-2009-00039
- Event Type
- Injury
- Date Received
- November 2, 2009
- Report Date
- October 19, 2009
- Manufacturer
- PEGASUS BIOLOGICS, INC.
- Product Code
- FTM
- PMA / PMN Number
- K071065
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT COULD NOT BE CONFIRMED. ADDITIONAL INFORMATION WAS REQUESTED FROM PHYSICIAN; HOWEVER, NO INFORMATION EVER WAS PROVIDED. PRODUCT LOT NUMBER IS NOT KNOWN. THE MANUFACTURER OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS, INC. SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC IS THE REPORTING COMPANY FOR THE EVENT. THE EVENT OCCURRED PRIOR TO SYNOVIS ACQUIRING PEGASUS BIOLOGICS.
Description of Event or Problem · 1
CASE WAS REPORTED AS AN EXPLANT OF AN ORTHADAPT BIOIMPLANT. NO CASE INFORMATION WAS PROVIDED, INCLUDING CASE TYPE AND SIGNS/ SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHADAPT BIOIMPLANT | SURGICAL MESH | FTM | PEGASUS BIOLOGICS, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |