FDA Adverse Event
Injury
Summary report: N
TEROSA
MDR report key: 3899179
·
Received May 29, 2014
Report
- Report Number
- 2125050-2014-00369
- Event Type
- Injury
- Date Received
- May 29, 2014
- Date of Event
- April 29, 2014
- Report Date
- May 27, 2014
- Manufacturer
- COLOPLAST A/S
- Product Code
- FAF
- PMA / PMN Number
- P020003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
AFTER FURTHER EVALUATION OF THE RETURNED DEVICE, COLOPLAST WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT. BASED ON THE EVALUATION, THE DEVICE PERFORMED AS INTENDED AND NO LEAKS WERE FOUND. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH TEROSA SALINE TESTICULAR (MED). LATER THE PATIENT EXPERIENCED THE DEVICE LOSING FLUID. AN EXPLANT OF THE DEVICE WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317325 | TEROSA | SALINE FILLED TESTICULAR PROSTHESIS, PRODUCT CODE: FAF | FAF | COLOPLAST A/S | 5206302400 | 3698615 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |