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U.S. Department of Health and Human Services

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

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STRYKER MEDICAL-KALAMAZOO SM/M RAPR-ROUND KIT SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number 8001061550
Device Problem Insufficient Information (3190)
Patient Problem Pressure Sores (2326)
Event Date 04/14/2017
Event Type  Injury  
Manufacturer Narrative
Supplemental submitted to include udi. Device not returned.
 
Event Description
It was reported that allegedly a patient developed stage 2 pressure ulcers on the upper ankle area from the rapkit leg pads.
 
Event Description
It was reported that allegedly a patient developed stage 2 pressure ulcers on the upper ankle area from the rapkit leg pads.
 
Manufacturer Narrative
No further information regarding the alleged injury was made available. The account manager provided in servicing on the use of the pads.
 
Event Description
It was reported that allegedly a patient developed stage 2 pressure ulcers on the upper ankle area from the rapkit leg pads.
 
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Brand NameSM/M 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 Key6560257
MDR Text Key108002078
Report Number0001831750-2017-00191
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
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 Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8001061550
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2017
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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