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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC INSTANT COLD PACK; PACK, HOT OR COLD, DISPOSABLE
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CARDINAL HEALTH 200, LLC INSTANT COLD PACK; PACK, HOT OR COLD, DISPOSABLE Back to Search Results
Catalog Number 11445-020
Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Chemical Spillage (2894)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2015
Event Type  malfunction  
Event Description
Allergy clinic nurse attempted to activate chemical cold pack for use following immunotherapy injections.The pack burst, spraying contents onto patient's clothing and the treatment area, but did not come in contact with skin or mucus membranes.This is the second of two events over two days with cold packs from the same lot.Manufacturer response for instant cold pack size medium, (brand not provided) (per site reporter): i have contacted the manufacturer local rep.Awaiting instructions for rep to obtain item for inspection by manufacturer.
 
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Brand Name
INSTANT COLD PACK
Type of Device
PACK, HOT OR COLD, DISPOSABLE
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
808 w highway 24
moberly MO 65270
MDR Report Key5179814
MDR Text Key29303206
Report Number5179814
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 Patient
Type of Report Initial
Report Date 09/28/2015,10/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Nurse
Device Catalogue Number11445-020
Device Lot NumberV6J296
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/28/2015
Event Location Hospital
Date Report to Manufacturer09/28/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/27/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Age10 YR
Patient Weight30
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