FDA Adverse Event
Injury
Summary report: N
MITEK GII ANCHOR
MDR report key: 53758
·
Received December 2, 1996
Report
- Report Number
- 1221934-1996-00005
- Event Type
- Injury
- Date Received
- December 2, 1996
- Date of Event
- June 1, 1996
- Report Date
- November 29, 1996
- Manufacturer
- MITEK SURGICAL PRODUCTS, INC.
- Product Code
- KGS
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT DEVELOPED INFECTION IN SMALL FINGER AFTER SURGERY. INFECTION WAS NOT CULTURED, TREATED SUCCESSFULLY WITH ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MITEK GII ANCHOR Implant | SUTURE ANCHOR | KGS | MITEK SURGICAL PRODUCTS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |