PERMATAPE 280781Recalls & reported problems
Medos International Sàrl · PERMATAPE Suture White-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 10886705032778), received between Feb 24, 2025 and Feb 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Use of Device Problem1
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.
MalfunctionFeb 24, 2025Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN THE SURGEON ATTEMPTED TO INSERT THE PERMATAPE 1.3 W/B DEVICE INTO THE INSIDE ANCHOR, HE FELT A STUCK SENSATION. ACCORDING TO THE REPORTER, WHEN THE SURGEON PULLED THE DEVICE BACK ONCE TO CHECK, IT WAS FOUND THAT THERE WAS A KNOT IN THE TAPE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21444428 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.