FDA Adverse Event
Injury
Summary report: N
AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
MDR report key: 4918965
·
Received July 16, 2015
Report
- Report Number
- 2183959-2015-00314
- Event Type
- Injury
- Date Received
- July 16, 2015
- Date of Event
- April 6, 2015
- Report Date
- July 10, 2015
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- OTP
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 ANTERIOR, THE PATIENT EXPERIENCED MILD "LEFT SIDE PELVIC PAIN". NO INTERVENTION HAS BEEN PERFORMED AND THE EVENT IS CONSIDERED TO BE CONTINUING. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED DISCOMFORT. AS OF (B)(6) 2016, THE EVENT WAS STILL CONSIDERED CONTINUING. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462111 | 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 |