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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; WHEELCHAIR
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; WHEELCHAIR Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Hip Fracture (2349)
Event Date 09/12/2017
Event Type  Injury  
Event Description
Patient was heard yelling out for help.Patient was found laying flat on her back with w/c next to her.Patient was trying to transfer to her bed and just fell.According to the administrator at the facility, the staff assumed that the patient did not lock her w/c and attempted to transfer herself from the w/c to bed when she fell.Md notified and new order for a portable x-ray obtained.X-ray showed probable fracture.Family chose not to send to the hospital for further evaluation.On (b)(6) 2017 the patient had increased pain in her right leg.Family decided to take her to (b)(6) hospital, er for further evaluation.Patient went to the hospital per ambulance.X-ray completed and showed confirmed fracture of the right hip.Daughter chose no further interventions and the patient returned to the facility with comfort measures only.Patient is bed bound with hip precautions used to keep right hip in alignment with pillows.Pain medication used.
 
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Brand Name
UNK
Type of Device
WHEELCHAIR
MDR Report Key6984427
MDR Text Key90632771
Report Number6984427
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 User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/10/2017
Distributor Facility Aware Date09/14/2017
Device Age NA
Event Location Other
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age84 YR
Patient Weight64
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