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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO NARROW TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT
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STRYKER MEDICAL-KALAMAZOO NARROW TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number 3500000705
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 10/16/2014
Event Type  Injury  
Event Description
It was reported via repair work order that the nurse activated the recliner and allegedly it injured her leg.The extent of the injury was not reported.A technician evaluated the unit and no malfunction or defect was found, and no correction required.
 
Event Description
It was reported via repair work order that the nurse activated the recliner and allegedly it injured her leg.The extent of the injury was not reported.A technician evaluated the unit and no malfunction or defect was found, and no correction required.
 
Manufacturer Narrative
Supplemental report submitted as it was determined the nurse received a scrape to her leg that was treated with a band aid, with no additional medical intervention required.
 
Manufacturer Narrative
At filing date, several calls to the facility for further information regarding the alleged injury have not been returned.If additional information is obtained, a supplemental report will be filed as necessary.
 
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Brand Name
NARROW 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 Key4249708
MDR Text Key5050568
Report Number0001831750-2014-03343
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 Nurse
Type of Report Initial,Followup
Report Date 10/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number3500000705
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/16/2014
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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