FDA Adverse Event
Injury
Summary report: N
AMS RETROARC RETROPUBIC SLING SYSTEM
MDR report key: 5340842
·
Received January 4, 2016
Report
- Report Number
- 3011770902-2016-00001
- Event Type
- Injury
- Date Received
- January 4, 2016
- Date of Event
- December 18, 2015
- Report Date
- December 28, 2015
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- OTN
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER A RETROARC WAS IMPLANTED, THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTIONS. THE PATIENT'S SYMPTOMS INCLUDED URINARY INCONTINENCE, URGENCY AND NOCTURIA. THE EVENT WAS CONSIDERED MILD. THE PATIENT WAS PRESCRIBED CIPROBAY 500 MG TWICE DAILY FOR 5 DAYS, FOLLOWED BY MACROBID 100 MG DAILY FOR 3 MONTHS AS WELL AS DALACIN VAGINAL CREAM FOR 7 DAYS, ALL STARTING ON (B)(6) 2015. THE EVENT WAS CONSIDERED CONTINUING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Description of Event or Problem · 1
IT WAS ADDITIONALLY REPORTED THAT AS OF (B)(6) 2016, THE EVENT WAS CONSIDERED CONTINUING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2674 | AMS RETROARC RETROPUBIC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |