FDA Adverse Event
Malfunction
Summary report: N
12.4CM HEAVY DUTY LONG ATTACHMENT
MDR report key: 3080954
·
Received April 24, 2013
Report
- Report Number
- 1045834-2013-02032
- Event Type
- Malfunction
- Date Received
- April 24, 2013
- Date of Event
- March 28, 2013
- Report Date
- March 29, 2013
- Manufacturer
- THE ANSPACH EFFORT, INC.
- Product Code
- HBC
- PMA / PMN Number
- K011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY ANSPACH. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT DURING A MAINTENANCE CHECK, THE DEVICE WAS "RUNNING HOT". THE DEVICE WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176280 | 12.4CM HEAVY DUTY LONG ATTACHMENT | HBC | THE ANSPACH EFFORT, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |