FDA Adverse Event
Injury
Summary report: N
UNKNOWN SLING
MDR report key: 5443930
·
Received February 18, 2016
Report
- Report Number
- 3011770902-2016-00067
- Event Type
- Injury
- Date Received
- February 18, 2016
- Date of Event
- January 26, 2015
- Report Date
- February 8, 2016
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- PAH
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6) 2008
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN UNKNOWN DEVICE REMOVED. IT WAS ALSO NOTED THAT THE DEVICE MALFUNCTIONED. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102090 | UNKNOWN SLING | UNKNOWN | PAH | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |