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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DYAD MEDICAL SOURCING,LLC HCS COLD PACKS; PACK COLD INSTANT, DISPOSABLE
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DYAD MEDICAL SOURCING,LLC HCS COLD PACKS; PACK COLD INSTANT, DISPOSABLE Back to Search Results
Catalog Number HCS1101
Device Problem Burst Container or Vessel (1074)
Patient Problem Exposure to Body Fluids (1745)
Event Date 01/25/2018
Event Type  malfunction  
Event Description
This was completed by a nurse in recovery: ice pack activated next to patient's bedside and it exploded liquid.Patient had lacrilube in eyes previously from surgery.Patient reported drop in left eye, but no discomfort.Nurse immediately rinsed with saline.Notified doctor and pharmacist.Patient dad at bedside and aware.Msds obtained.Gsu rn updated.Patient denies any discomfort or vision issues.Agrees to notify rn if problems.Per site reporter: i spoke to customer service and the quality manager is off today.They will send me shipping label.
 
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Brand Name
HCS COLD PACKS
Type of Device
PACK COLD INSTANT, DISPOSABLE
Manufacturer (Section D)
DYAD MEDICAL SOURCING,LLC
2101 waukegan rd. ste 208
bannockburn IL 60015
MDR Report Key7288744
MDR Text Key100682656
Report Number7288744
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/26/2018,02/13/2018
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 Catalogue NumberHCS1101
Device Lot Number170904
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/26/2018
Event Location Hospital
Date Report to Manufacturer01/26/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Age32 YR
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