FDA Adverse Event
Injury
Summary report: N
MALE REEMEX SYSTEM
MDR report key: 1410356
·
Received July 7, 2009
Report
- Report Number
- 3006621295-2009-00001
- Event Type
- Injury
- Date Received
- July 7, 2009
- Date of Event
- June 12, 2009
- Report Date
- June 29, 2009
- Manufacturer
- DIMA S.L.
- Product Code
- FTL
- PMA / PMN Number
- K062341
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SENT LETTER TO PATIENT TO ASK FOR THE DEVICE TO BE ANALYZED AT MANUFACTURING FACILITY.
Description of Event or Problem · 1
THE PATIENT SENT A LETTER ANNOUNCING HE HAD AN IMPORTANT INFECTION AND URINARY RETENTION AFTER IMPLANT OF TWO MALE REMEEX SYSTEMS. ACTUAL SITUATION IS THAT HE IS NOW INCONTINENT AFTER SYSTEM EXPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALE REEMEX SYSTEM | FTL | DIMA S.L. | MRS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |