FDA Adverse Event
Other
Summary report: N
ZYPLAST COLLAGEN IMPLANT (VOLUME UNSPECIFIED)
MDR report key: 827279
·
Received March 9, 2007
Report
- Report Number
- 2024601-2007-00137
- Event Type
- Other
- Date Received
- March 9, 2007
- Date of Event
- May 22, 2006
- Report Date
- February 8, 2007
- Manufacturer
- INAMED CORP (FREMONT)
- Product Code
- GAX
- PMA / PMN Number
- P800022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
TWO DAYS AFTER INJECTION OF ZYPLAST INTO THE BALANUS, THE PT FIRST REPORTED PAIN AT THE AREA BETWEEN THE PENIS AND TESTIS. IN 2006, THE NECROSIS WAS OBSERVED AT THE EPIDERMIS OF THE BALANUS. THE PURPLE SPOT, PIGMENTATION AND ULCER SCAR STILL REMAIN AT THE LOWER EPITHELIZATION SITE. ADD'L TREATMENT WAS PRESCRIBED BUT IT IS NOT KNOWN WHAT WAS PRESCRIBED AT THIS TIME. THIS EVENT IS BEING REPORTED BECAUSE OF ALLERGAN'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZYPLAST COLLAGEN IMPLANT (VOLUME UNSPECIFIED) | INJECTABLE COLLAGEN IMPLANT | GAX | INAMED CORP (FREMONT) | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention| S |