MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F5; POWERED WHEELCHAIR

Model Number	F5
Medical Device Problem Codes	Mechanical Problem (1384); Structural Problem (2506); Sharp Edges (4013)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permobil received report indicating an injury having occurred to the end-user as they were in process of performing a transfer from the device seating to the toilet.Report claims as the end-user was in mid transfer, their foot slipped off of the device footplate.Upon reaching the toilet, the end-user noticed their socked foot was bleeding.Reports received claim the end-user went to the hospital where they received 10 stitches to 2nd phalange on the left foot.It was noted none of the other phalanges sustained injury.The end-user initially reported the footplate as having a sharp edge and that it was the cause of the injury, but after further inspection noted the footplate did not have the sharp edges as they initially suspected.The end-user reports not knowing what may have caused the injury.The dhr was reviewed and device met specification prior to distribution.At this time, permobil is unable to determine the possible cause of the reported injury as device has not been made available for inspection.Permobil has requested the service provider to inspect the device, surroundings in which the event occurred and the end-user's transfer technique.Upon the receipt of new information, a follow-up report will be submitted.
Event or Problem Description
Received report claiming while the end-user was performing a transfer, their foot slipped off the footplate assembly which reportedly caused the toe next to their large toe to become cut.It was reported the end-user sought medical intervention to resolve.
Additional Manufacturer Narrative
Permobil representative met with the end-user in their home to access the device and the environment in which the injury was alleged to have occurred.Inspection found the device to be fully operational with no notable deviations or malfunctions.Device components were examined for any abnormalities which would present a sharp edge; to which there were none noted.The end-user explained the procedure he used for transfer when the incident allegedly occurred.The end-user nor the permobil representative could make a determination as to how the injury was inflicted without speculation.No known issues were found with the device or the environment in which it being used.No further investigation will be performed.

• Brand Name: PERMOBIL F5
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 9035533
• Report Number: 1221084-2019-00040
• Device Sequence Number: 16689663
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: F5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 98