FDA Adverse Event
Injury
Summary report: N
MINIARC PRECISE SLING SYSTEM
MDR report key: 3042203
·
Received April 4, 2013
Report
- Report Number
- 2183959-2013-00772
- Event Type
- Injury
- Date Received
- April 4, 2013
- Date of Event
- March 11, 2013
- Report Date
- March 27, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- PAH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
ON (B)(6) 2012, THE PT WAS IMPLANTED WITH A MINIARC PRECISE FOR THE TREATMENT OF URINARY INCONTINENCE. IT WAS REPORTED THAT ON (B)(6) 2013 THERE WAS EXPOSURE OF THE SLING AND THE PHYSICIAN TRIMMED THE MATERIAL. THE PT HAS NOT FOLLOWED-UP WITH THE PHYSICIAN SINCE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 137875 | MINIARC PRECISE SLING SYSTEM | SURGICAL MESH | PAH | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R| S |