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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO RAPR-ROUND KIT LARGE; SYSTEM, THERMAL REGULATING
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STRYKER MEDICAL-KALAMAZOO RAPR-ROUND KIT LARGE; SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number RAPKIT-L
Device Problem Insufficient Information (3190)
Patient Problem Erythema (1840)
Event Date 11/25/2014
Event Type  Injury  
Event Description
It was reported that a patient received redness of skin after using the meditherm wrap.Further information was not provided.
 
Event Description
It was reported that a patient received redness of skin after using the meditherm wrap.Further information was not provided.
 
Manufacturer Narrative
It was confirmed by the user facility that the patient had pre-existing conditions due to the medication that may have caused the redness.The customer indicated that there were no malfunctions with the product.The device was not made available for further evaluation.H3 other text : device not returned.
 
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Brand Name
RAPR-ROUND KIT LARGE
Type of Device
SYSTEM, THERMAL REGULATING
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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key4338901
MDR Text Key5216251
Report Number0001831750-2014-03421
Device Sequence Number1
Product Code DWJ
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,Followup
Report Date 11/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberRAPKIT-L
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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