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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT
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STRYKER MEDICAL-KALAMAZOO TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number 3500000710
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Fall (1848); Injury (2348)
Event Date 06/02/2016
Event Type  Injury  
Event Description
It was reported a visitor was sitting in a recliner and could not get the footrest to go down.The visitor exited the chair by placing both feet outside of the ottoman, and reportedly fell while trying to stand up.It was alleged the visitor hurt their knee and ankle, but no additional details regarding the severity of the alleged injuries were provided.
 
Manufacturer Narrative
The unit was evaluated and no malfunction or defect was found.
 
Event Description
It was reported a visitor was sitting in a recliner and could not get the footrest to go down.The visitor exited the chair by placing both feet outside of the ottoman, and reportedly fell while trying to stand up.It was alleged the visitor hurt their knee and ankle, but no additional details regarding the severity of the alleged injuries were provided.
 
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Brand Name
TREATMENT RECLINER
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 Key5808672
MDR Text Key49981684
Report Number0001831750-2016-00232
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number3500000710
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2015
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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