FDA Adverse Event
Injury
Summary report: N
AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
MDR report key: 4093092
·
Received September 16, 2014
Report
- Report Number
- 2183959-2014-00411
- Event Type
- Injury
- Date Received
- September 16, 2014
- Date of Event
- December 14, 2012
- Report Date
- August 20, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS (MN)
- Product Code
- OTP
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE ONE MONTH AFTER AN ELEVATE PC ANTERIOR AND APICAL GRAFT WAS IMPLANTED. NO INTERVENTION HAD OCCURRED. THE EVENT WAS ONGOING AS OF (B)(6) 2014 NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. RELATED TO MANUFACTURER REPORT NO. 2183959-2014-00412.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573003 | AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | SURGICAL MESH | OTP | AMERICAN MEDICAL SYSTEMS (MN) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |