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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD MEDICHOICE BARIATRIC XD WHEELCHAIR

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ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD MEDICHOICE BARIATRIC XD WHEELCHAIR Back to Search Results
Model Number 2867WCBAR26E
Device Problems Inadequate or Insufficient Training (1643); Use of Device Problem (1670)
Patient Problems Crushing Injury (1797); Laceration(s) (1946)
Event Date 04/10/2019
Event Type  Injury  
Event Description

A cna and patient's daughter were assisting the patient into a bariatric xd wheelchair (650 lb. Weight capacity). Apparently the wheelchair was not fully extended, and locked into an open position. The patient positioned herself into the chair by holding on to the edge of the wheelchair seat. Upon applying her weight to the seat, the chair fully extended and opened, and the patient's small finger was caught between the seat support tube and the underneath cradle. The distal tip of the phalanx, left small finger, was noted to be amputated and bleeding. The patient was taken into surgery for a reattachment of the distal tip. The patient was re-admitted to the hospital and upon release was to follow-up with her primary care physician.

 
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Brand NameMEDICHOICE BARIATRIC XD WHEELCHAIR
Type of DeviceBARIATRIC XD WHEELCHAIR
Manufacturer (Section D)
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD
zhongshan, guandong
CH
MDR Report Key8592876
MDR Text Key144544976
Report Number2428983-2019-00002
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2867WCBAR26E
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/08/2019
Distributor Facility Aware Date04/15/2019
Device Age8 yr
Event Location Hospital
Date Report TO Manufacturer05/07/2019
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

Patient TREATMENT DATA
Date Received: 05/08/2019 Patient Sequence Number: 1
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