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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TEMPERATURE THERAPY PAD; PACK, HOT OR COLD, WATER CIRCULATING
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STRYKER MEDICAL-KALAMAZOO TEMPERATURE THERAPY PAD; PACK, HOT OR COLD, WATER CIRCULATING Back to Search Results
Catalog Number TP626E
Device Problems Hole In Material (1293); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2015
Event Type  malfunction  
Event Description
It was reported that the temperature therapy pad was leaking due to a hole in the pad.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
The issue was noticed before the product was used.The blanket was not made available for further evaluation.
 
Event Description
It was reported that the temperature therapy pad was leaking due to a hole in the pad.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
TEMPERATURE THERAPY PAD
Type of Device
PACK, HOT OR COLD, WATER CIRCULATING
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 Key4943944
MDR Text Key6039817
Report Number0001831750-2015-00362
Device Sequence Number1
Product Code ILO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor,distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberTP626E
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/01/2015
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
Patient Sequence Number1
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