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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROTHREADS LLC EUROTHREADS; NEEDLE, SUTURING, DISPOSABLE
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EUROTHREADS LLC EUROTHREADS; NEEDLE, SUTURING, DISPOSABLE Back to Search Results
Lot Number ISO1385
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Bruise/Contusion (1754); Pain (1994); Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/16/2020
Event Type  Injury  
Event Description
I had euro threads (eurothreadslift.Com) implemented 8 weeks ago, and have had all possible side effects, including bruises, pain, two infections (currently treated with antibiotics and steroids), face asymmetry, trauma, etc.The pain and infection continues.My physician recommended to remove these threads as they may damage my nerve permanently.I'm very unsatisfied with this procedure and eurothreads.They should not be fda approved as they are dangerous and can cause permanent damage.After two months of the procedure i have constant pain and occasionally numbing.Please contact me.I can give you the lot number of the product and the aesthetician business name who performed that procedure.
 
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Brand Name
EUROTHREADS
Type of Device
NEEDLE, SUTURING, DISPOSABLE
Manufacturer (Section D)
EUROTHREADS LLC
MDR Report Key10843375
MDR Text Key216890753
Report NumberMW5097879
Device Sequence Number1
Product Code GAB
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Lot NumberISO1385
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 Age48 YR
Patient Weight63
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