FDA Adverse Event
Other
Summary report: N
COSMODERM 2 COLLAGEN IMPLANT (0.5ML)
MDR report key: 1051337
·
Received May 20, 2008
Report
- Report Number
- 2024601-2008-00261
- Event Type
- Other
- Date Received
- May 20, 2008
- Date of Event
- February 5, 2008
- Report Date
- April 21, 2008
- Manufacturer
- INAMED CORP. (FREMONT)
- Product Code
- LMH
- PMA / PMN Number
- P800022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MEDWATCH SENT TO FDA ON 05/20/2008. DEVICE EVALUATION SUMMARY: QUALITY ASSURANCE HAS REVIEWED THE DEVICE HISTORY RECORDS FOR THIS LOT FROM FINISHED PRODUCT PACKAGING TO THE MESH BATCH. ALL STERILITY, BIOBURDEN, PYROGEN (RABBIT) AND LAL TESTING WAS PERFORMED AS REQUIRED AND ALL TESTS PASSED. DURING REVIEW OF THE DEVICE HISTORY RECORDS, MINOR DEVIATIONS WERE NOTED. NONE OF THE DEVIATIONS NOTED WERE SIGNIFICANT NOR WOULD CONTRIBUTE TO A CAUSE FOR THIS COMPLAINT. BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, I FIND NO ASSIGNABLE CAUSE FOR THIS COMPLAINT.
Description of Event or Problem · 1
AFTER TREATMENT WITH COSMODERM 2 IN THE FOREHEAD AND LEFT CHEEK FOR SHALLOW SCARS, THE PATIENT'S RESULT WAS DEEPER SCARS. THE PATIENT WAS TREATED WITH NITROPASTE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COSMODERM 2 COLLAGEN IMPLANT (0.5ML) | INJECTABLE COLLAGEN IMPLANT | LMH | INAMED CORP. (FREMONT) | NA | 06A021C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |