FDA Adverse Event
Injury
Summary report: N
SALINE TESTICULAR, LARGE
MDR report key: 480677
·
Received August 29, 2003
Report
- Report Number
- 2125050-2003-00361
- Event Type
- Injury
- Date Received
- August 29, 2003
- Date of Event
- July 30, 2003
- Report Date
- August 18, 2003
- Manufacturer
- MENTOR CORP. - MINNESOTA DIVISI
- Product Code
- FAF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DESCRIBE EVENT OR PROBLEM: THERE WAS LEAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SALINE TESTICULAR, LARGE | TESTICULAR PRODUCT | FAF | MENTOR CORP. - MINNESOTA DIVISI | 450-1329 | 789535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Hospitalization| R |