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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem Tissue Breakdown (2681)
Event Date 03/14/2014
Event Type  malfunction  
Event Description
It was reported by the user facility that the patient's skin allegedly broke down while on the mattress.No patient was affected and no adverse consequence or 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.No patient was affected and no adverse consequence or 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 Key3747515
MDR Text Key4464701
Report Number0001831750-2014-02884
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? 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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