MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F3 CORPUS; POWERED WHEELCHAIR

Model Number	F3 CORPUS
Medical Device Problem Codes	Misassembled (1398); Use of Device Problem (1670); Misassembly During Maintenance/Repair (4054)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Tissue Breakdown (2681)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Received claim that due to improper positioning of power wheelchair seating, resulted in a pressure ulcer on left foot requiring multiple surgeries to address.
Additional Manufacturer Narrative
Permobil counsel received a letter of civil complaint against permobil claiming negligence in failure to provide product with proper positioning needs for the end-user which reportedly led to the end-user developing a stage 4 pressure ulcer on their left foot requiring multiple surgeries to address, eventually leading to the amputation of the left foot.In the claim it is alleged that permobil failed to build the device according to specification in that an 18" wide backrest was ordered, but permobil provided a 16" wide.Review of device history records indicates a 16" wide back was originally quoted by dealer, ordered, and device shipped with a 16"w back.The petition also claims a bent footplate as also being a contributing factor with the reported injury, and that service parts were required to correct.Review of device history records does not have any supporting evidence of permobil being contacted to replace or repair any components related to an alleged malfunction as described.The primary allegation is the failure to meet the end-user's specific physical requirements and provide adequate support to meet their physical needs.Permobil records indicate the device having been built to specification, and that no product malfunction having occurred to which this reported event can be attributed.Permobil is unable to reach a determination as to possible root cause of the event without speculation.The dhr was reviewed, and the device was found to have met specifications prior to distribution.

• Brand Name: PERMOBIL F3 CORPUS
• 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: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 17693012
• Report Number: 1221084-2023-00018
• Device Sequence Number: 6378691
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2023

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: F3 CORPUS
• 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: 08/18/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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