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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 11/24/2020
Event Type  malfunction  
Event Description
It was reported that the chair tipped over when the patient shifted their weight.The patient fell onto their right arm/shoulder and reported pain but declined medical treatment.The device was inspected by a stryker service technician; no defect was found with the product that could have contributed to the reported malfunction.Additional information about the injury has been requested.
 
Manufacturer Narrative
The complaint investigation has been completed.Through investigation it was identified that this was a minor injury and not a serious one.The record has been updated to reflect this.
 
Event Description
It was reported that the chair tipped over when the patient shifted their weight.The patient fell onto their right arm/shoulder and reported pain but declined medical treatment.The device was inspected by a stryker service technician; no defect was found with the product that could have contributed to the reported malfunction.
 
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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 Key11056691
MDR Text Key241251762
Report Number0001831750-2020-01226
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 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 12/04/2020
Initial Date FDA Received12/22/2020
Supplement Dates Manufacturer Received12/04/2020
Supplement Dates FDA Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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