FDA Adverse Event
Other
Summary report: N
ADVANCE MALE SLING SYSTEM
MDR report key: 3130034
·
Received May 22, 2013
Report
- Report Number
- 2183959-2013-00843
- Event Type
- Other
- Date Received
- May 22, 2013
- Date of Event
- April 19, 2013
- Report Date
- April 22, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTM
- Removal / Correction Number
- Z-0808-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THE ADVANCE MESH WAS IMPLANTED ON (B)(6) 2013. THE MESH WAS PART OF THE RECALLED MESH AND WAS INADVERTENTLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226681 | ADVANCE MALE SLING SYSTEM | SURGICAL MESH, POLYMERIC | OTM | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other |