MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M5; POWERED WHEELCHAIR

Model Number	M5
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Tissue Breakdown (2681)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
End-user reported having been battling a recurring pressure ulcer which had started to develop on their back, just above the coccyx region, for approximately 3 weeks.Over that time the ulcer has reportedly grown to stage 3 and requires surgery to address.The end-user reported having home health aides help diagnose the possible cause and they speculated it was from the compression of the foam on the back cushion allowing the zippers that attach the cushion cover to press through and create a pressure point.Photos of the cushion (taken by the end-user) appear to depict indentations in the foam material where the zippers terminate, but not to the point of diminishment of the foam material.Inquiries made to the end-users therapist indicate they found the roho seat cushion had been under inflated which changed the end-users positioning, potentially forcing the end-user to apply more pressure on their lower back, thus compressing the foam material.Review of device history and analysis of complaint data indicate no other reports of this nature have been received by permobil.Permobil is unable to confirm a product malfunction occurred to have caused this reported event, thus are unable to reach a determination as to root cause without speculation.The dhr was reviewed, and device was found to have met specification prior to distribution.
Event or Problem Description
Permobil received report from the end-user of having sustained a pressure ulcer on their back due to an alleged flaw in design with the cover of the backrest cushion.

• Brand Name: PERMOBIL M5
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 15200660
• Report Number: 1221084-2022-00014
• Device Sequence Number: 19373723
• Product Code: ITI
• UDI-Device Identifier: 17330818334562
• UDI-Public: 17330818334562
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: M5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose