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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 Device Operates Differently Than Expected (2913)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 10/10/2014
Event Type  malfunction  
Event Description
It was reported by the customer that a patient fell and sustained a sacral fracture when the footrest of the recliner experienced a false latch situation.
 
Manufacturer Narrative
The user facility was able to identify the unit involved in the alleged complaint (serial number (b)(4)); it was evaluated and found to be working to specification.
 
Event Description
It was reported by the customer that a patient fell and sustained a sacral fracture when the footrest of the recliner experienced a false latch situation.
 
Manufacturer Narrative
Unit involved in the alleged incident could not be identified by the account, therefore no inspection was performed.
 
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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-NEW YORK
10 centre drive
orchard park NY 14127
Manufacturer Contact
mary klaver
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key4235927
MDR Text Key5532132
Report Number0001831750-2014-03324
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 10/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number3500000730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received10/10/2014
Was Device Evaluated by Manufacturer? No
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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