MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC. WHITMEYER HEADREST

Model Number HU-MTLCV

Device Problem Scratched Material (3020)

Patient Problem Tissue Breakdown (2681)

Event Date 04/07/2014

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: WHITMEYER HEADREST
• Type of Device: HEADREST
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC.; fresno CA 93727
• Manufacturer Contact: jeremy ybarra, ra/qa specialist ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 3799696
• MDR Text Key: 17954981
• Report Number: 2937137-2014-00014
• Device Sequence Number: 1
• Product Code: IMS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HU-MTLCV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 50