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