MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M3; POWERED WHEELCHAIR

Model Number	M3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abrasion (1689); Physical Entrapment (2327); Skin Tears (2516)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The report provided claims the end-user had just transferred into the wheelchair seating from their bed and immediately connected the wheelchair's positioning belt.The end-user claims that before they could tighten the positioning belt, they reportedly slid off the cushion to the side of the seating.The end-user explained that due to their physical disability, they were unable to pull themselves upright and they were left hanging off the side of the seating with the positioning belt across their abdomen for approximately 10 hours.The end-user was admitted to the hospital with reports of ligature tearing in the abdominal region and severe knee abrasions.The end-user maintains the wheelchair itself did not malfunction or cause the slip and fall, but instead alleges that the cushion was slippery.Review of device history indicates the wheelchair was shipped without a seat cushion.The end-user confirmed that their dme dealer supplied them with a cushion manufactured by a third-party company.Based on the end-user's testimony, it is permobil's contention the most probable cause for this event was inadvertent user error in losing their balance while improperly secured via the installed positioning belt.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report from end-user stating that they experienced an incident after transferring into the wheelchair seating and securing the positioning belt.After clipping the belt but before tightening it up fully, the end-user reportedly slipped off the cushion to the side of the seating.Because the end-user did not have the physical ability to get back into the chair or unclip the positioning belt, they was reportedly suspended by the positioning belt for an extended period.This allegedly resulted in injuries requiring medical intervention.

• Brand Name: PERMOBIL M3
• 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: 17100828
• Report Number: 1221084-2023-00011
• Device Sequence Number: 16627288
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/09/2023

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: M3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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: Hospitalization
• Patient Sex: Prefer Not To Disclose