FDA Adverse Event
Injury
Summary report: N
AMS MONARC SLING SYSTEM
MDR report key: 3915120
·
Received July 7, 2014
Report
- Report Number
- 2183959-2014-00275
- Event Type
- Injury
- Date Received
- July 7, 2014
- Date of Event
- January 21, 2014
- Report Date
- June 13, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS (MN)
- Product Code
- OTN
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RELATED TO MFR REPORT NUMBER: 2183959-2014-00055. IT WAS REPORTED THAT FOLLOWING A MONARC SLING IMPLANTATION, THE PATIENT IS EXPERIENCING INCONTINENCE. IT WAS INDICATED THAT THE EVENT IS CONTINUING AS OF (B)(6) 2014. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT'S STRESS URINARY INCONTINENCE WAS RESOLVED ON (B)(6) 2014. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393983 | AMS MONARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | AMERICAN MEDICAL SYSTEMS (MN) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |