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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Pain (1994)
Event Date 10/13/2015
Event Type  Injury  
Event Description
It was reported via repair work order that a patient allegedly fell out of the recliner and was found on the floor.The patient was not able to speak well and was, therefore, unable to describe the event.The patient indicated shoulder pain and was taken for x-rays where it was determined there were no broken bones or other damage.The recliner was found to be working within specifications.
 
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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
rita moffitt
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key5234409
MDR Text Key31570807
Report Number0001831750-2015-00580
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 Nurse
Type of Report Initial
Report Date 10/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number3500000730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2015
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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