MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-04-22 for WHITMEYER HEADREST HU-MTLCV manufactured by Sunrise Medical (us) Llc..
[17954981]
A dealer reported to sunrise medical that an end-user has sustained skin breakdown behind her right ear. The dealer is alleging that sharp metal edges on the headrest pad are what is causing the skin breakdown.
Patient Sequence No: 1, Text Type: D, B5
[18097363]
It appears that the wheelchair and/or parts involved in this incident are being returned to sunrise medical (us) llc. If and when the chair/parts are rec'd, our internal failure investigator will complete the investigation and a f/u report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937137-2014-00014 |
| MDR Report Key | 3799696 |
| Report Source | 07 |
| Date Received | 2014-04-22 |
| Date of Report | 2014-04-07 |
| Date of Event | 2014-04-07 |
| Date Mfgr Received | 2014-04-07 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2014-05-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEREMY YBARRA, RA/QA SPECIALIST |
| Manufacturer Street | 2842 BUSINESS PARK AVE. |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal | 93727 |
| Manufacturer Phone | 5592942840 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHITMEYER HEADREST |
| Generic Name | HEADREST |
| Product Code | IMS |
| Date Received | 2014-04-22 |
| Model Number | HU-MTLCV |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL (US) LLC. |
| Manufacturer Address | FRESNO CA 93727 US 93727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-22 |