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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
Model Number 8002-062-022
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/16/2020
Event Type  malfunction  
Event Description
It was reported that the pad was leaking while engaged on the bed.The patient was not affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported that the pad was leaking while engaged on the bed.The patient was not affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
It was identified that the device was most likely cut by a knife puncturing the pad during unpacking.This could not be confirmed as this device was not returned for evaluation.Updated catalog number.H3 other text: device not accessible for evaluation.
 
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Brand Name
TEMP THERAPY PAD BOX OF 20
Type of Device
PACK, HOT OR COLD, WATER CIRCULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10750809
MDR Text Key213665344
Report Number0001831750-2020-01192
Device Sequence Number1
Product Code ILO
UDI-Device Identifier07613327175202
UDI-Public07613327175202
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8002-062-022
Device Catalogue Number8002062012
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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