MAUDE Adverse Event Report: PDO MAX PDO THREADS; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDO THREADS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was treated without complication.26 days after treatment, the patient called reporting some tenderness and something firm below her skin.She reported that she thought it was a cystic acne lesion and reported self treating for 5 days with "alcohol, sulfur, retinol and hot compress" in an effort to "dry it up".Patient had a red raised lesion that she stated was tender to touch which started after self treatment.The patient was prescribed doxycycline and mupirocin, by the treating physician, that she reported taking for 4 days but did not wish to continue.The patient was then prescribed keflex, bactrim and clindamycin 1% topical wipes by the treating physician.Ultrasound was done and did not find a cyst.The abscess was cultured and results were negative.The patient reported she is doing well 46 days after the initial procedure and 20 days after reporting the issue.

• Brand Name: PDO THREADS
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): PDO MAX; 4971 bear road; suite 102; liverpool NY 13088
• Manufacturer (Section G): PDO MAX; 4971 bear road; suite 102; liverpool NY 13088
• Manufacturer Contact: juliana koval ; 4971 bear road; suite 102; liverpool, NY 13088 ; 3157270681
• MDR Report Key: 25660750
• Report Number: 3015289316-2026-00001
• Device Sequence Number: 13374965
• Product Code: NEW
• UDI-Device Identifier: 00850018324632
• UDI-Public: 00850018324632
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PDO THREADS
• Device Catalogue Number: LEVO 18X100
• Device Lot Number: YR25120120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown