MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M300; POWER WHEELCHAIR

Model Number	M300
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permobil technical support was contacted by the end-user's mother inquiring if permobil provided alternative solutions for the footplates to accommodate the end-user.During the inquiry, the mother reported an incident having occurred where the end-user, or a caregiver, inadvertently drove the device into an un-descript object allowing the end-user's feet to collide.The collision resulted with the end-user sustaining 4 broken toes requiring medical intervention to address.The mother reported the device is equipped with aftermarket padded foot supports, but the end-user's feet are longer than the support and their toes hang over the edge leaving them exposed.The mother did not report any malfunction having occurred with the device to have contributed to this event.Permobil recommended the end-user contact their dealer/provider to re-assess and provide alternative solutions to meet the client's current needs.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report indicating the end-user, or a caregiver, having inadvertently collided into an un-descript object with the footplates of the power wheelchair resulting in a serious injury requiring medical intervention.

• Brand Name: PERMOBIL M300
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke dr.; lebanon TN 37090
• MDR Report Key: 12366579
• Report Number: 1221084-2021-00027
• Device Sequence Number: 15215474
• Product Code: ITI
• UDI-Device Identifier: 17330818123401
• UDI-Public: 17330818123401
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: M300
• 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: 08/03/2021
• Initial Report FDA Received Date: 08/25/2021
• 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