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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAIR PRO - MODEL 6252; STRETCHER, HAND-CARRIED

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STAIR PRO - MODEL 6252; STRETCHER, HAND-CARRIED Back to Search Results
Catalog Number 6252000000
Device Problems Difficult or Delayed Positioning (1157); Device Fell (4014)
Patient Problems Muscle/Tendon Damage (4532); Insufficient Information (4580)
Event Date 05/13/2021
Event Type  Injury  
Event Description
It was reported that a caregiver may have injured their back while using the device.Further information has not been provided at this time.
 
Manufacturer Narrative
As a result this event, a visual and functional inspection was scheduled to be performed by field technician, the inspection was canceled as the customer did not want the repair to be performed at this time and the unit has not been further evaluated.The customer had alleged that the unit¿s treads seemed worn, however this could not be confirmed.The user facility said that the caregiver had a back injury as a result and went to the hospital to be checked out and then sent home.They are still not cleared for work and still seeking treatment.H3 other text: device not accessible for evaluation.
 
Event Description
It was alleged that a caregiver received a back injury.As they came over the threshold of a step and started to go down the steps, one side let loose allegedly due to the rubber tracks, and the stair chair twisted and dropped on the steps.
 
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Brand Name
STAIR PRO - MODEL 6252
Type of Device
STRETCHER, HAND-CARRIED
MDR Report Key11984186
MDR Text Key255659786
Report Number0001831750-2021-00955
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6252000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/14/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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