MAUDE Adverse Event Report: PERMOBIL PERMOBIL F5 CORPUS; WHEELCHAIR, POWERED

Device Problem Device Fell (4014)

Patient Problems Fall (1848); Confusion/ Disorientation (2553)

Event Date 07/05/2022

Event Type  Injury  

Event Description

Powered wheelchair with docking bracket caused damage to ramp resulting in the catastrophic failure of the ramp while the user was in the chair and on the ramp.It appears that due to low ground clearance, the qlk docking bracket/bolt installed on the bottom of the chair caused rivets within a home entry ramp to shear.The chair and user fell, and the user was briefly disoriented, but sustained no apparent injuries at that time.However the user required assistance in order to get free of the incident site/debris and to reenter the user's home.Fda safety report id# (b)(4).

• Brand Name: PERMOBIL F5 CORPUS
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): PERMOBIL
• MDR Report Key: 15055042
• MDR Text Key: 296225209
• Report Number: MW5110943
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ESTRADIOL ; METFORMIN ; SERTRALINE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 113 KG
• Patient Ethnicity: Hispanic
• Patient Race: White