FDA Adverse Event
Other
Summary report: N
C-FLEX POLAR HEAD POSITIONER
MDR report key: 2860285
·
Received November 28, 2012
Report
- Report Number
- 1221538-2012-00018
- Event Type
- Other
- Date Received
- November 28, 2012
- Report Date
- October 31, 2012
- Manufacturer
- ALLEN MEDICAL
- Product Code
- FWZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A FINAL REPORT WILL BE PREPARED WHEN THE HEAD POSITIONER IS RETURNED AND THE EVAL IS COMPLETED.
Description of Event or Problem · 1
A DISTRIBUTOR IN (B)(4) REPORTED THAT AN INSPECTOR REJECTED A C-FLEX HEAD POSITIONER ON RECEIPT BECAUSE IT DID NOT PASS INCOMING INSPECTION CRITERIA FOR LOAD TESTING. THERE WAS NO PT INVOLVEMENT AND THE PRODUCT WAS NOT PUT INTO USE. THE UNIT WILL BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-FLEX POLAR HEAD POSITIONER | C-FLEX, SURGICAL HEAD POSITIONER | FWZ | ALLEN MEDICAL | A-70701-A2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |