FDA Adverse Event
Injury
Summary report: N
AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
MDR report key: 3813610
·
Received May 15, 2014
Report
- Report Number
- 2183959-2014-00156
- Event Type
- Injury
- Date Received
- May 15, 2014
- Date of Event
- September 24, 2013
- Report Date
- April 25, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS (MN)
- Product Code
- OTP
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD A "REPAIR OF CYSTOCELE" ON (B)(6) 2015. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2015. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE PC POSTERIOR GRAFT THE PATIENT PRESENTED WITH MODERATE "DE-NOVO CYSTOCELE." A "VAGINAL BULGE NOTICED BY PATIENT WHEN PASSING URINE IN THE MORNING, SHE HAS TO GO TO THE TOILET SEVERAL TIMES TO EMPTY BLADDER." THE EVENT IS CONSIDERED CONTINUING (NOT RESOLVED) AS OF(B)(6) 2014. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290285 | AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | SURGICAL MESH | OTP | AMERICAN MEDICAL SYSTEMS (MN) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |