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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LOWBACK CHAIR W/O ARMS 18IN; CHAIR AND TABLE, MEDICAL
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STRYKER MEDICAL-KALAMAZOO LOWBACK CHAIR W/O ARMS 18IN; CHAIR AND TABLE, MEDICAL Back to Search Results
Catalog Number 3500000220
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2016
Event Type  malfunction  
Event Description
It was reported that the wooden frame of the chair had split potentially not supporting weight.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Follow-up submitted with evaluation results which determined the product sustained shipping damage and was replaced.
 
Event Description
It was reported that the wooden frame of the chair had split potentially not supporting weight.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
LOWBACK CHAIR W/O ARMS 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
rita moffitt
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key5447027
MDR Text Key39041972
Report Number0001831750-2016-00057
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 company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number3500000220
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/24/2016
Initial Date FDA Received02/19/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/26/2016
Was Device Evaluated by Manufacturer? Yes
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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