FDA Adverse Event
Injury
Summary report: N
ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM
MDR report key: 3231433
·
Received July 15, 2013
Report
- Report Number
- 2183959-2013-00922
- Event Type
- Injury
- Date Received
- July 15, 2013
- Date of Event
- June 12, 2013
- Report Date
- June 28, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT WAS IMPLANTED WITH AN ELEVATE ANTERIOR GRAFT. THE PATIENT EXPERIENCED DELAYED MICTURITION, WHICH RESULTED FROM RESIDUAL URINE. IT WAS REPORTED THAT THE PATIENT WAS ADMINISTERED TAMSULOSIN AND HAD "INTERMITTENT CATHETER" ON (B)(6) 2013. IT WAS REPORTED THE DELAYED MICTURITION RESOLVED ON (B)(6) 2013. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327796 | ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |