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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TEMP THERAPY PAD BOX OF 20; PACK, HOT OR COLD, WATER CIRCULATING
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STRYKER MEDICAL-KALAMAZOO TEMP THERAPY PAD BOX OF 20; PACK, HOT OR COLD, WATER CIRCULATING Back to Search Results
Catalog Number 8002062012
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.The device was not evaluated, as the issue was identified and resolved during a troubleshooting call between the customer and stryker technical support.There was no remedial action taken.This device is not labeled for single use.
 
Event or Problem Description
This report summarizes 1 malfunction event(s), where it was reported fluid leaked onto the patient.There were no reported adverse consequences related to the incident.
 
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Brand Name
TEMP THERAPY PAD BOX OF 20
Common Device Name
PACK, HOT OR COLD, WATER CIRCULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key9237950
Report Number0001831750-2019-01099
Device Sequence Number16617314
Product Code ILO
UDI-Device Identifier07613327261288
UDI-Public07613327261288
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number8002062012
Device Lot NumberVMSR
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/01/2019
Initial Report FDA Received Date10/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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