FDA Adverse Event
Injury
Summary report: N
SALINE TESTICULAR, MEDIUM
MDR report key: 507648
·
Received January 23, 2004
Report
- Report Number
- 2125050-2004-00011
- Event Type
- Injury
- Date Received
- January 23, 2004
- Date of Event
- December 18, 2003
- Report Date
- December 30, 2003
- Manufacturer
- MENTOR CORP. - MINNESOTA DIVISION
- Product Code
- FAF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCORDING TO THE INFORMATION TESTICULAR DEVICE LEAKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SALINE TESTICULAR, MEDIUM | TESTICULAR PRODUCTS | FAF | MENTOR CORP. - MINNESOTA DIVISION | 450-1327 | 90496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Hospitalization| R |