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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 Problems Device Slipped (1584); Patient Device Interaction Problem (4001)
Patient Problems Laceration(s) (1946); Insufficient Information (4580)
Event Date 04/28/2021
Event Type  malfunction  
Event Description
It was reported that a patient sustained an injury related to the treatment recliner.No additional information has been provided regarding the event, severity, or treatment of the injury.
 
Manufacturer Narrative
Investigation is complete, h codes updated to reflect the investigation results.After the investigation, it was determined that the adverse event was a minor injury.Codes updated to reflect this change.
 
Event Description
It was reported that a patient sustained an injury related to the treatment recliner.Upon further communication with the customer, it was found that the reported injury was a laceration.Multiple attempts were made to gather treatment details, but the customer did not respond to these attempts.
 
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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
MDR Report Key11872672
MDR Text Key254328818
Report Number0001831750-2021-00916
Device Sequence Number1
Product Code FRK
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 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
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
Date Manufacturer Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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