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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACNE SPOT DOTS; DRESSING, WOUND, OCCLUSIVE
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ACNE SPOT DOTS; DRESSING, WOUND, OCCLUSIVE Back to Search Results
Device Problem Material Integrity Problem (2978)
Patient Problems Scarring (2061); Skin Discoloration (2074); Injury (2348)
Event Date 03/03/2018
Event Type  Injury  
Event Description
I purchased "peach & lily" "acne spot dots" and applied three of them to three closed red pimples on my chin.When i removed them, i had horrible burns with pus oozing out of them.I am left with three indented scars on my chin with discoloration surrounding them.I can provide photos if needed.I reached out to the company and requested a complete list of the product's ingredients and reported the burns.I received a one word answer: "hydrocolloid." no one has contacted me to follow up on my report.Peach & lily."is the product compounded: no.Is the product over-the-counter: yes." quantity: 3 dots, frequency: one use, how was it taken or used: stuck onto skin.Date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018."why was the person using the product: acne.Did the problem stop after the person reduced the dose or stopped taking or using the product: no; did the problem return if the person started taking or using the product again: didn't restart." facial burns and scarring.
 
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Brand Name
ACNE SPOT DOTS
Type of Device
DRESSING, WOUND, OCCLUSIVE
MDR Report Key7658580
MDR Text Key113287291
Report NumberMW5078226
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age47 YR
Patient Weight64
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