FDA Adverse Event
Injury
Summary report: N
ZYPLAST COLLAGEN IMPLANT (1.0ML)
MDR report key: 1253086
·
Received December 5, 2008
Report
- Report Number
- 2024601-2008-01037
- Event Type
- Injury
- Date Received
- December 5, 2008
- Date of Event
- September 15, 2008
- Report Date
- November 11, 2008
- Manufacturer
- INAMED CORP. (FREMONT)
- Product Code
- LMH
- PMA / PMN Number
- P800022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MEDWATCH SENT TO FDA ON 12/05/2008. DEVICE EVALUATION SUMMARY: QUALITY ASSURANCE HAS REVIEWED THE DEVICE HISTORY RECORDS FOR THIS LOT FROM FINISHED PRODUCT PACKAGING TO THE HIDE BATCH. ALL STERILITY, BIOBURDEN, PYROGEN (RABBIT) AND LAL TESTING WAS PERFORMED AS REQUIRED AND ALL TESTS PASSED. DURING REVIEW OF THE DEVICE HISTORY RECORDS, A MINOR DEVIATION WAS NOTED. THE DEVIATION NOTED WAS NOT SIGNIFICANT NOR WOULD CONTRIBUTE TO A CAUSE FOR THIS COMPLAINT. BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, WE FIND NO ASSIGNABLE CAUSE FOR THIS COMPLAINT.
Description of Event or Problem · 1
TWO MONTHS AFTER TREATMENT WITH ZYPLAST IN THE BALANUS, THE PATIENT PRESENTED WITH NECROSIS AT THE INJECTION SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZYPLAST COLLAGEN IMPLANT (1.0ML) | INJECTABLE COLLAGEN IMPLANT | LMH | INAMED CORP. (FREMONT) | NA | 07K021D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |