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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6252; STRETCHER, HAND-CARRIED
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STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6252; STRETCHER, HAND-CARRIED Back to Search Results
Catalog Number 6252000000
Device Problem Device Tipped Over (2589)
Patient Problem Pain (1994)
Event Date 07/31/2020
Event Type  Injury  
Event Description
It was reported that a user was injured while transporting a patient up the stairs, likely due to the chair tipping.The customer reported the user was hospitalized due to a "significant" back injury which resulted in missing several days of work and continued use of a walker.
 
Manufacturer Narrative
The facility did not make the device available for evaluation.They stated the issue was likely caused by user error, but this could not be confirmed by stryker.Facility did not make the device available for evaluation.
 
Event Description
It was reported that a user was injured while transporting a patient up the stairs, likely due to the chair tipping.The customer reported the user was hospitalized due to a "significant" back injury which resulted in missing several days of work and continued use of a walker.
 
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Brand Name
STAIR PRO - MODEL 6252
Type of Device
STRETCHER, HAND-CARRIED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10445502
MDR Text Key204178011
Report Number0001831750-2020-00890
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 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6252000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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