FDA Adverse Event
Injury
Summary report: N
AMS MINIARC PRO SINGLE INCISION SLING SYSTEM
MDR report key: 5388752
·
Received January 25, 2016
Report
- Report Number
- 3011770902-2016-00049
- Event Type
- Injury
- Date Received
- January 25, 2016
- Date of Event
- March 12, 2015
- Report Date
- January 23, 2016
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- PAH
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF A MINIARC PRO, THE PATIENT EXPERIENCED EXPECTED POST-OPERATIVE (POST-OP) INCISION PAIN. THE PATIENT WAS PRESCRIBED PERCOCET AND ADVIL, AS NEEDED, ON (B)(6) 2015. THE PATIENT STATED THAT THE MEDICATIONS WERE "KEEPING HER COMFORTABLE". THE PATIENT ALSO EXPERIENCED NORMAL EXPECTED POST-OP BLEEDING. THE EVENT WAS CONSIDERED RESOLVED/RECOVERED WITH NO SEQUELAE ON (B)(6) 2015. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT. RELATED TO MFR # 3011770902-2016-00048.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47454 | AMS MINIARC PRO SINGLE INCISION SLING SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, MINI-SLING | PAH | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | HYSTEROPEXY |