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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: N/A N/A

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Model Number N/A
Device Problems Frame (820); Break (1069); Material Integrity Problem (2978)
Patient Problems Laceration(s) (1946); Injury (2348)
Event Date 08/07/2016
Event Type  Injury  
Event Description

The consumer/end-user reported that the wheelchair's frame cracked while he was driving it around his mother's pool. The frame cracked where the wheels go into it. The end-user had to go to the hospital, and received 12 stitches from falling forward. The end-user is on disability.

Event Description

Device was returned to compass health brands, and evaluated on 9/16/2016. Upon inspection, the unit was found to be used with heavy wear, and a lot of rust. The customer stated that the frame cracked where the wheels go into the frame. The customer is correct, the frame just above the weld where the caster wheel cylinder slides into has cracked. The left side wheel has completely detached from the wheelchair due to the cracked/broken frame. The ride side is cracked in the same spot, but the caster wheel is still attached. Both armrest cushions are ripped, and the foam is exposed.

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Brand NameN/A
Type of DeviceN/A
Manufacturer (Section D)
MDR Report Key5911678
MDR Text Key53398514
Report Number3005182235-2016-00025
Device Sequence Number1
Product Code IOR
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 10/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/10/2016
Distributor Facility Aware Date08/11/2016
Event Location Other
Date Report TO Manufacturer08/29/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Date Received: 08/29/2016 Patient Sequence Number: 1