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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 8002062022
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2016
Event Type  malfunction  
Event Description
It was alleged that the temperature therapy pad was leaking during use.Further information has not been provided.
 
Manufacturer Narrative
The customer reported that the product was not available for evaluation.The device was not returned for evaluation.
 
Event Description
It was alleged that the temperature therapy pad was leaking during use.Further information has not been provided.
 
Manufacturer Narrative
Supplemental submitted to include udi.The device was not returned for evaluation.
 
Event Description
It was alleged that the temperature therapy pad was leaking during use.Further information has not been provided.
 
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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
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6194214
MDR Text Key63360388
Report Number0001831750-2016-00409
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 user facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number8002062022
Device Lot NumberUNKNOWN2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/28/2016
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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