FDA Adverse Event
Injury
Summary report: N
MONARC SLING SYSTEM
MDR report key: 2142357
·
Received June 20, 2011
Report
- Report Number
- 2183959-2011-00214
- Event Type
- Injury
- Date Received
- June 20, 2011
- Date of Event
- May 23, 2011
- Report Date
- June 9, 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 ADD'L INFO BECOMES AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MONARC SLING WAS IMPLANTED ON (B)(6) 2008. REPORTEDLY AFTER IMPLANT, THE PT EXPERIENCED "CONSTANT PAIN". THE PHYSICIAN SAID, THE PRIMARY SOURCE OF HER PAIN WAS THE MESH THAT HE DESCRIBED AS HAVING "WIRE THREADS AND A JELLO-LIKE COATING ON IT." THIS DOES NOT DESCRIBE AN AMS FEMALE MESH PRODUCT. THE MESH WAS REMOVED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONARC SLING SYSTEM | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |