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PERMATAPE 280778Recalls & reported problems

Medos International Sàrl · PERMATAPE Suture Blue Braided Tape 1.3mm 36" (91cm) · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705032747), received between Aug 7, 2023 and Aug 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (1 report).

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

Device problems

  • Migration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 7, 2023Migration; Migration

    IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP BIOCOMPOSITE ANCHOR DEVICE CAME OUT WHEN THE SURGEON PULLED OUT THE SHAFT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. .

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17471440 ↗

Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices

All SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.