FDA Adverse Event
Malfunction
Summary report: N
6.5CM ADULT CRANI ATTACHMT
MDR report key: 3042643
·
Received April 2, 2013
Report
- Report Number
- 1045834-2013-01154
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Date of Event
- July 27, 2011
- Report Date
- August 2, 2011
- Manufacturer
- THE ANSPACH EFFORT, INC.
- Product Code
- HBC
- PMA / PMN Number
- K011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
THE REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS "HEATING AFTER 2 MINUTE ROTATION". THE DEVICE WAS NOT BEING USED IN SURGERY. THERE WAS NO REPORTED PT OR USER INJURIES. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134473 | 6.5CM ADULT CRANI ATTACHMT | HBC | THE ANSPACH EFFORT, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |