FDA Adverse Event
Other
Summary report: N
ALLEN WING SET SYSTEM
MDR report key: 1964101
·
Received January 11, 2011
Report
- Report Number
- 1221538-2011-00002
- Event Type
- Other
- Date Received
- January 11, 2011
- Date of Event
- December 2, 2010
- Report Date
- December 13, 2010
- Manufacturer
- ALLEN MEDICAL SYSTEMS
- Product Code
- FWZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN ALLEN REP FAMILIAR WITH THE WINGSETS AND THEIR USE, EVALUATED THE PRODUCT AT THE HOSPITAL WITH THE USER STAFF. NO ISSUES OR DEFECTS WERE FOUND. PRIOR TO THIS INCIDENT, THE REP REPORTS VISITING THE FACILITY SEVERAL TIMES AND HAS PERFORMED NUMEROUS IN-SERVICE SESSIONS WITH USERS. THERE WAS NO CLEAR INDICATION OF IMPROPER POSITIONING, HE SAID.
Description of Event or Problem · 1
SURGEON REPORTED A POST-OPERATIVE TRANSITORY FEMORAL NERVE PALSY ISSUE FOLLOWING A POSITIONING CASE IN WHICH THE ALLEN WINGSETS PRODUCT WAS USED. THE STAFF AT MIDWEST ORTHOPEDIC SPECIALTY HOSPITAL REPORTED THAT THE PT, A LIFETIME DIABETIC, RECOVERED FULLY AFTER A FEW DAYS OF TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEN WING SET SYSTEM | WING SETS SYSTEM | FWZ | ALLEN MEDICAL SYSTEMS | A-70200-A3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |