FDA Adverse Event
Injury
Summary report: N
AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
MDR report key: 4216300
·
Received October 31, 2014
Report
- Report Number
- 2183959-2014-00483
- Event Type
- Injury
- Date Received
- October 31, 2014
- Date of Event
- September 13, 2013
- Report Date
- November 27, 2013
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- OTP
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ZA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE PC ANTERIOR GRAFT THE PATIENT PRESENTED WITH MILD DE-NOVO STRESS URINARY INCONTINENCE. SHE "EXPERIENCED STRESS URINARY INCONTINENCE ON TWO OCCASIONS WITH A FULL BLADDER AND SNEEZING." THE EVENT IS CONSIDERED CONTINUING (NOT RESOLVED) AS OF (B)(6) 2013. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.
Description of Event or Problem · 1
IT WAS ADDITIONALLY REPORTED THAT AS OF (B)(6) 2016, THE EVENT WAS STILL CONSIDERED ONGOING. NO INTERVENTION WAS TAKEN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 699670 | AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | SURGICAL MESH | OTP | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |