FDA Adverse Event
Malfunction
Summary report: N
XMAX MOTOR
MDR report key: 3000171
·
Received February 14, 2013
Report
- Report Number
- 1045834-2013-00221
- Event Type
- Malfunction
- Date Received
- February 14, 2013
- Date of Event
- January 10, 2013
- Report Date
- January 18, 2013
- Manufacturer
- THE ANSPACH EFFORT, INC.
- Product Code
- ERL
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY INSPACH. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS NOTED TO HAVE A "MUCH LOUDER NOISE" OF OPERATION AND THE DEVICE WAS NOT ABLE TO HOLD THE BURR IN PLACE DURING SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65392 | XMAX MOTOR | ERL | THE ANSPACH EFFORT, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |