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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JIANGSU INTCO MEDICAL PRODUCTS CO.LTD MCKESSON BRANDS; COMPRESS, COLD INST 6"X9"
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JIANGSU INTCO MEDICAL PRODUCTS CO.LTD MCKESSON BRANDS; COMPRESS, COLD INST 6"X9" Back to Search Results
Catalog Number 16-9703
Device Problems Leak/Splash (1354); Packaging Problem (3007)
Patient Problems Full thickness (Third Degree) Burn (2696); Blister (4537)
Event Date 10/06/2022
Event Type  Injury  
Event Description
Patient initially reported to her healthcare provider that a cold pack she was given leaked and caused a 2nd degree burn.Instructions for use were not followed.The patient was given a cream for treatment.The patient later went to a second doctor and verbally communicated that the second doctor told her that her burn was 3rd degree.It was communicated that the burn was healing.This mdr is being filed based upon the communication of a 3rd degree burn.
 
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Brand Name
MCKESSON BRANDS
Type of Device
COMPRESS, COLD INST 6"X9"
Manufacturer (Section D)
JIANGSU INTCO MEDICAL PRODUCTS CO.LTD
77# yandunshan road
dagang zhenjiang, jiangsu 21213 2
CH  212132
MDR Report Key15764663
MDR Text Key303387979
Report Number1451040-2022-00057
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 Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number16-9703
Device Lot NumberCITA10-16
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/09/2022
Distributor Facility Aware Date10/28/2022
Device Age12 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer11/09/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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