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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO XPRT W/O PENDANT W/DARTEX; BED, PATIENT ROTATION, POWERED
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STRYKER MEDICAL-KALAMAZOO XPRT W/O PENDANT W/DARTEX; BED, PATIENT ROTATION, POWERED Back to Search Results
Catalog Number 2950200002
Device Problem Insufficient Information (3190)
Patient Problems Pressure Sores (2326); Tissue Breakdown (2681)
Event Date 03/14/2014
Event Type  Injury  
Event Description
It was reported by the user facility that the patient's skin allegedly broke down while on the mattress.There was patient involvement; however, no clinically relevant delay in treatment was reported.
 
Event Description
It was reported by the user facility that the patient's skin allegedly broke down while on the mattress.There was patient involvement; however, no clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Follow-up submitted with evaluation results which determined the mattress performed to specifications and no defect was found.
 
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Brand Name
XPRT W/O PENDANT W/DARTEX
Type of Device
BED, PATIENT ROTATION, POWERED
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
pravin betala
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3747455
MDR Text Key4447096
Report Number0001831750-2014-02882
Device Sequence Number1
Product Code IKZ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2950200002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/20/2014
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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