FDA Adverse Event
Injury
Summary report: N
AMS MINIARC SLING SYSTEM
MDR report key: 3901491
·
Received June 30, 2014
Report
- Report Number
- 2183959-2014-16311
- Event Type
- Injury
- Date Received
- June 30, 2014
- Date of Event
- June 25, 2008
- Report Date
- March 17, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- PAH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFFS ATTORNEY THAT THE PLAINTIFF EXPERIENCED BURNING AND DIFFICULT URINATION, BACK PAIN, INABILITY TO VOID, INCONTINENCE, NOCTURIA, DYSURIA, FREQUENCY, ABDOMINAL AND FLANK PAIN, PELVIC PHLEBOLITHS AND TINY NON OBSTRUCTING RENAL CALCULI. THE DEVICE REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379482 | AMS MINIARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | PAH | AMERICAN MEDICAL SYSTEMS | 720046-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Disability |