Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.The patient was not affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
It was found, that the pad assembly was cut cleanly in two places.Which was mirrored across one of the packaging folds in the blanket.Therefore, it was determined, that the pad was likely cut by a knife, during unpacking.Which went through both sides of the fold in the blanket.Updated catalog number and added lot number.
 
Event Description
It was reported, that the pad was leaking.The patient was not affected.And no adverse consequence or clinically relevant delay in treatment was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11165030
MDR Text Key226650947
Report Number0001831750-2021-00023
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
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 Number1120A4
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/29/2020
Initial Date FDA Received01/13/2021
Supplement Dates Manufacturer Received12/29/2020
Supplement Dates FDA Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-