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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PATIENT ROOM WALL SAVER RECL; CHAIR, EXAMINATION AND TREATMENT
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STRYKER MEDICAL-KALAMAZOO PATIENT ROOM WALL SAVER RECL; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number 3500000730
Device Problem Collapse (1099)
Patient Problem Fall (1848)
Event Date 05/11/2016
Event Type  malfunction  
Event Description
It was reported that a patient was sitting in the recliner and leaned over to cover their feet with a blanket, and the footrest collapsed, causing the patient to roll out of the recliner.No adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Supplemental submitted with results of evaluation.It was confirmed there were no alleged injuries associated with the reported event.
 
Event Description
It was reported that a patient was sitting in the recliner and leaned over to cover their feet with a blanket, and the footrest collapsed, causing the patient to roll out of the recliner.No adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
PATIENT ROOM WALL SAVER RECL
Type of Device
CHAIR, EXAMINATION AND TREATMENT
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
mary klaver
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key5717823
MDR Text Key48155408
Report Number0001831750-2016-00192
Device Sequence Number1
Product Code FRK
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 05/13/2016
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 Number3500000730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/13/2016
Initial Date FDA Received06/10/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2015
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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