FDA Adverse Event
Injury
Summary report: N
SURGITEK TESTICULAR IMPLANT
MDR report key: 191844
·
Received October 14, 1998
Report
- Report Number
- 2182596-1998-00270
- Event Type
- Injury
- Date Received
- October 14, 1998
- Report Date
- September 21, 1998
- Manufacturer
- MEDICAL ENGINEERING CORP.
- Product Code
- FAF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALLEGATIONS OF IMPLANT RUPTURE AND UNSPECIFIED INJURIES DUE TO IMPLANTATION. SILICONE GRANULOMA REMOVED ON 02/02/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGITEK TESTICULAR IMPLANT Implant | TESTICULAR IMPLANT | FAF | MEDICAL ENGINEERING CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |