FDA Adverse Event
Injury
Summary report: N
AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
MDR report key: 5385846
·
Received January 22, 2016
Report
- Report Number
- 3011770902-2016-00043
- Event Type
- Injury
- Date Received
- January 22, 2016
- Date of Event
- December 30, 2015
- Report Date
- January 19, 2016
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- OTP
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE ANTERIOR, THE PATIENT EXPERIENCED A LOWER URINARY TRACT INFECTION. THE "SOC POST OP" VISIT URINALYSIS (UA) WAS POSITIVE FOR NITRITE AND LEUKOCYTES ON (B)(6) 2015; IT WAS SENT FOR CULTURE AND SENSITIVITY. THE PATIENT WAS PRESCRIBED NITROFURANTOIN 100 MG BID X5 DAYS ON (B)(6) 2015. THE UA WAS THEN REPEATED AND CAME BACK NEGATIVE ON (B)(6) 2016. THE EVENT WAS CONSIDERED RESOLVED/RECOVERED WITH NO SEQUELAE AS OF (B)(6) 2016. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT. RELATED TO MFR# 3011770902-2016-00047
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45265 | AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | SURGICAL MESH | OTP | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | MINIARC PRECISE |