PDO Max Threads PM18100L-SERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850018324632), received between Jun 29, 2026 and Jun 29, 2026 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Abscess

  MAUDE report 25660750 ↗