FDA Adverse Event
Other
Summary report: N
OVERHEAD COUNTERPOISE SYSTEM
MDR report key: 209108
·
Received February 5, 1999
Report
- Report Number
- 2520313-1999-00008
- Event Type
- Other
- Date Received
- February 5, 1999
- Date of Event
- December 29, 1998
- Report Date
- February 5, 1999
- Manufacturer
- F. WALTER HANEL GMGH
- Product Code
- DXT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE OVERHEAD COUNTERPOISE SYSTEM (OCS) BROKE ALLOWING THE ARM AND THE INJECTOR HEAD TO DROP. NO INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OVERHEAD COUNTERPOISE SYSTEM | OVERHEAD COUNTERPOISE SYSTEM | DXT | F. WALTER HANEL GMGH | OCS115 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |