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

Model Number	F3 CORPUS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neck Pain (2433); Muscle/Tendon Damage (4532)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Service provider reports being called out to inspect the device for damages sustained due to a report of the device having fallen over.Report claims as the end-user was in process of driving up a handicap ramp, there was a section of that ramp that was missing, and the end-user didn't see it until they drove over.This reportedly caused the device to become unstable and fall over to the right-hand side, with the end-user.The end-user reported having been taken to the local hospital emergency room where they were diagnosed as sustaining some whiplash and possible ligament damage to their right shoulder.Neither the end-user nor the service technician made any claim or allegation that the device deviated or malfunctioned in any way to have contributed to this event.All accounts indicate the device was fully operational prior to the event, with information provided from the end-user claiming it was the missing portion of the ramp that allowed the device to drop in and lose upright stability.Dealer stated there is considerable damage to the wheelchair because of the event, and recommendation was provided by permobil that the device be replaced vs.Repair due to the potential for imperceptible damages, which if gone un-noticed, may render the device unsafe for future use.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming while the end-user was driving up a handicap ramp, there was a missing section in the ramps surface.When driven over allowed the drive wheel to drop down causing the chair, with the end-user, to tip over on its side.This resulted with the end-user sustaining injuries requiring medical intervention.

• 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: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 12770520
• Report Number: 1221084-2021-00038
• Device Sequence Number: 3119391
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• 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: Female
• Patient Weight: 127 KG