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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY 3M RED DOT; ELECTRODE, ELECTROCARDIOGRAPH

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3M COMPANY 3M RED DOT; ELECTRODE, ELECTROCARDIOGRAPH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Burning Sensation (2146); Blister (4537); Skin Inflammation/ Irritation (4545)
Event Date 03/10/2021
Event Type  Injury  
Event Description
Itching, severe irritation, blistering and burning of skin.Fda safety report id# (b)(4).
 
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Brand Name
3M RED DOT
Type of Device
ELECTRODE, ELECTROCARDIOGRAPH
Manufacturer (Section D)
3M COMPANY
MDR Report Key11506725
MDR Text Key240690738
Report NumberMW5100047
Device Sequence Number1
Product Code DRX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/16/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
Patient Weight138
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