FDA Adverse Event
Injury
Summary report: N
AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
MDR report key: 3820578
·
Received May 20, 2014
Report
- Report Number
- 2183959-2014-00166
- Event Type
- Injury
- Date Received
- May 20, 2014
- Date of Event
- July 25, 2013
- Report Date
- May 7, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS (MN)
- Product Code
- OTP
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE PC ANTERIOR, THE PATIENT EXPERIENCED MODERATE "VAGINAL EROSION, DEFECT HEALING" AND THE "MESH PARTLY VISIBLE." SURGERY WAS PERFORMED ON (B)(6) 2013 AND THE EVENT WAS REPORTED AS RESOLVED SAME DAY. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED INDICATED "TRANSVAGINAL COMPLETE MESH REMOVAL" 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 |
|---|---|---|---|---|---|---|---|
| 300212 | AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | SURGICAL MESH | OTP | AMERICAN MEDICAL SYSTEMS (MN) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |