FDA Adverse Event
Injury
Summary report: N
MINIARC
MDR report key: 2123195
·
Received June 10, 2011
Report
- Report Number
- 2183959-2011-00188
- Event Type
- Injury
- Date Received
- June 10, 2011
- Date of Event
- May 18, 2011
- Report Date
- May 18, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
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
REPORTEDLY SOMETIME IN (B)(6) 2011, THIS PATIENT HAD A MINIARC SLING IMPLANTED. APPROXIMATELY 4 MONTHS LATER, THE PATIENT "STARTED TO FEEL PINCHING INSIDE". DURING AN EXAMINATION BY A PHYSICIAN, THE PATIENT WAS FOUND TO HAVE MESH PROTRUDING THROUGH HER VAGINAL WALL, BELIEVED TO BE THE CAUSE OF HER PAIN. THE PATIENT HAD AN OUT-PATIENT PROCEDURE TO REVISE THE MESH SLING. DETAILS OF THE PATIENT OUTCOME AND PROCEDURE WERE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIARC | SINGLE-INCISION SLING | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |