FDA Adverse Event
Other
Summary report: N
C-FLEX POLAR HEAD POSITIONER
MDR report key: 2578611
·
Received May 14, 2012
Report
- Report Number
- 1221538-2012-00002
- Event Type
- Other
- Date Received
- May 14, 2012
- Report Date
- April 16, 2012
- Manufacturer
- ALLER MEDICAL SYSTEMS
- Product Code
- FWZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO PT INVOLVEMENT WITH THIS OUT OF BOX COMPLAINT. THE UNIT WAS TO BE SENT BACK FOR EVALUATION. WHEN THE UNIT IS RECEIVED FOR EVALUATION AND THE ENGINEERING INVESTIGATION IS COMPLETED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
ON (B)(4) 2012, A DISTRIBUTOR IN (B)(4) CONTACTED ALLEN TO REPORT A NEW C-FLEX HEAD POSITIONER REPORTEDLY DID NOT PASS AN OUT-OF-BOX SPECIFICATION DURING THEIR TESTING. THERE WAS NO PT INVOLVEMENT WITH THIS UNIT, THE DISTRIBUTOR REPORTED. THE UNIT WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-FLEX POLAR HEAD POSITIONER | SURGICLA HEAD POSITIONER | FWZ | ALLER MEDICAL SYSTEMS | A-70701-A2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |