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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ECTODERMA DBA COSMOFRANCE NOVATHREADS; PDO SUTURE
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ECTODERMA DBA COSMOFRANCE NOVATHREADS; PDO SUTURE Back to Search Results
Device Problems Break (1069); Material Fragmentation (1261); Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problems Blurred Vision (2137); Discomfort (2330); Eye Pain (4467); Nodule (4551)
Event Date 02/25/2024
Event Type  Injury  
Event Description
On february (b)(6) 2024, the patient reported that they had a barbed pdo implanted on (b)(6) 2024.According to the patient, they experienced extreme pressure and pain along with blurry vision.Hcp confirmed that the thread broke, migrated into the lower eyelid area, and the hcp extracted the thread on (b)(6) 2024.The investigation is ongoing, and updates will be provided if and when they are available.
 
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Brand Name
NOVATHREADS
Type of Device
PDO SUTURE
Manufacturer (Section D)
ECTODERMA DBA COSMOFRANCE
2121 sw 3rd ave ste 500
miami FL 33129
Manufacturer (Section G)
ECTODERMA DBA COSMOFRANCE
2121 sw 3rd ave ste 500
miami FL 33129
MDR Report Key18992538
MDR Text Key338888927
Report Number3007895168-2024-00006
Device Sequence Number1
Product Code NEW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Nurse
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 02/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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