FDA Adverse Event
Injury
Summary report: N
NON-MCGHAN
MDR report key: 406155
·
Received July 19, 2002
Report
- Report Number
- 2939859-2002-00110
- Event Type
- Injury
- Date Received
- July 19, 2002
- Date of Event
- November 29, 2001
- Report Date
- June 7, 2002
- Manufacturer
- MCGHAM MEDICAL CORP. (FREMONT)
- Product Code
- LMH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOLLOW FINDINGS: NOT A PRODUCT MFG BY INAMED CORP.
Description of Event or Problem · 1
PATIENT WAS ALLEGEDLY INJECTED WITH BOVINE COLLAGEN IN A FOREHEAD SCAR JUST LEFT OF MIDLINE AT THE HAIRLINE. WITHIN 24 HOURS THE PATIENT HAD LOST VISION IN THE LEFT EYE. "CHOROIDAL INFARCTION, LIKELY DUE TO EMBOLIZATION OF THE POSTERIOR CILLIARY ARTERIES" WAS THE DIAGNOSIS BY CONSULTING PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NON-MCGHAN | NON-MMC | LMH | MCGHAM MEDICAL CORP. (FREMONT) | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Disability |