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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO HOSPITAL RECLINER- W/O TREND.; CHAIR, EXAMINATION AND TREATMENT
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STRYKER MEDICAL-KALAMAZOO HOSPITAL RECLINER- W/O TREND.; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number 3110040550
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 12/08/2015
Event Type  malfunction  
Manufacturer Narrative
The part required for repair is obsolete, and the service tech recommended the customer to discontinue use of the recliner and to replace the chair at their discretion.
 
Event Description
It was reported the backrest would not remain upright due to a damaged spring, and a nurse allegedly injured her back during use.It was further reported there was no brace or medication prescribed, but that the nurse was placed on light duty for several weeks following the incident.
 
Manufacturer Narrative
This reported was submitted in error, as this product is manufactured by flexsteel.Flexsteel, the manufacturer is responsible for all regulatory reporting and complaint handling and closure.This complaint was sent to flexsteel for regulatory reporting determination.
 
Event Description
It was reported the backrest would not remain upright due to a damaged spring, and a nurse allegedly injured her back during use.It was further reported there was no brace or medication prescribed, but that the nurse was placed on light duty for several weeks following the incident.
 
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Brand Name
HOSPITAL RECLINER- W/O TREND.
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 Key5793689
MDR Text Key50394175
Report Number0001831750-2016-00229
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 company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number3110040550
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2006
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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