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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LG RAPR-ROUND KIT SYSTEM, THERMAL REGULATING

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STRYKER MEDICAL-KALAMAZOO LG RAPR-ROUND KIT SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number 8001061560
Device Problem Insufficient Information (3190)
Patient Problem Swelling (2091)
Event Date 05/30/2017
Event Type  malfunction  
Manufacturer Narrative
Supplemental submitted to include udi. Not available for further evaluation.
 
Event Description
It was alleged by the customer that the patient formed blisters once they were put on the rap kit. Information about set temperature or mode was not known. The blisters did not appear to be friction related, they appeared to be water blisters in a pattern that matched the pattern on the wrap. There was no excessive moisture on the skin and the skin condition was checked every two hours.
 
Event Description
It was alleged by the customer that the patient formed blisters once they were put on the rap kit. Information about set temperature or mode was not known. The blisters did not appear to be friction related, they appeared to be water blisters in a pattern that matched the pattern on the wrap. There was no excessive moisture on the skin and the skin condition was checked every two hours.
 
Manufacturer Narrative
The device was not available for further evaluation. A review of the device manual identified that a potential cause as to why the patient had developed blisters may have been a use error related to not checking the patient's skin at frequent enough intervals or not properly evaluating the patient's skin condition prior to applying the device.
 
Event Description
It was alleged by the customer that the patient formed blisters once they were put on the rap kit. Information about set temperature or mode was not known. The blisters did not appear to be friction related, they appeared to be water blisters in a pattern that matched the pattern on the wrap. There was no excessive moisture on the skin and the skin condition was checked every two hours.
 
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Brand NameLG RAPR-ROUND KIT
Type of DeviceSYSTEM, 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
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6673182
MDR Text Key108006347
Report Number0001831750-2017-00274
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 user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8001061560
Device Lot NumberUNKNOWN1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2017
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 Initial

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