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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO HIGH BACK CHAIR 18IN; CHAIR AND TABLE, MEDICAL
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STRYKER MEDICAL-KALAMAZOO HIGH BACK CHAIR 18IN; CHAIR AND TABLE, MEDICAL Back to Search Results
Catalog Number 3500000110
Device Problem Collapse (1099)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2016
Event Type  malfunction  
Event Description
It was reported the backrest of the chair collapsed and could not support weight.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
The issue was resolved for the customer by replacing the chair.
 
Event Description
It was reported the backrest of the chair collapsed and could not support weight.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
HIGH BACK CHAIR 18IN
Type of Device
CHAIR AND TABLE, MEDICAL
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
chanda burghard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6199467
MDR Text Key63509599
Report Number0001831750-2016-00415
Device Sequence Number1
Product Code KMN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number3500000110
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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