PERMATAPE 223169Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705027897), received between Dec 9, 2019 and Dec 16, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2022Crack; Appropriate Device Problem Term/Code Not Available; Crack; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN SURGERY FOR FRACTURE OF PROXIMAL END OF HUMERUS AND GREATER TUBEROSITY FRACTURE ON 11/24/2022, IT WAS OBSERVED THAT THE PERMATAPE SUTURE, BLUE BRAIDED FLAT SUTURE, 2.5MM GOT DAMAGED AND FRAYED WHILE THE SURGEON WAS TRYING ATTACHING SUTURE NEEDLES TO THE PERMATAPES REPEATEDLY. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998591 ↗
• MalfunctionOct 26, 2022Difficult to Advance; Missing Information; Difficult to Advance; Missing Information

  THIS IS REPORT 1 OF 2 FOR PC-(B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A SUBSCAPULARIS TENDON SUTURING PROCEDURE ON THE RIGHT SHOULDER ON (B)(6) 2022 , THE SURGEON FELT SOME STRESS WHEN APPLYING THE PERMATAPE BECAUSE THERE WAS NO NEEDLE. IT TOOK TIME TO PASS THE TAPE THROUGH THE NEEDLE. IT WAS FURTHER REPORTED THAT THE PRODUCT STICKER WAS NOT ON THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY LESS THAN 30-MINUTE SURGICAL DELAY. 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 15675796 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, THE PERMATAPE 2.5 BLUE DEVICE WAS APPLIED TO THE PATIENT WITH METAL ALLERGY. IT WAS REPORTED THAT THE SURGEON WONDERED IF RAW MATERIALS USED IN THE DEVICES (CHROMIUM OXIDE, COBALT AND ALUMINUM) MIGHT HAVE AFFECTED THE PATIENT. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Local Reaction

  MAUDE report 12384907 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, THE PERMATAPE 2.5 BLUE DEVICE WAS APPLIED TO THE PATIENT WITH METAL ALLERGY. IT WAS REPORTED THAT THE SURGEON WONDERED IF RAW MATERIALS USED IN THE DEVICES (CHROMIUM OXIDE, COBALT AND ALUMINUM) MIGHT HAVE AFFECTED THE PATIENT. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Local Reaction

  MAUDE report 12384906 ↗
• MalfunctionDec 9, 2019Break; Break

  ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE DEVICE WILL NOT BE RETURNING FOR EVALUATION. THE AFFILIATE ALSO STATED ADDITIONAL DETAILS PERTAINING TO THE CASE OR PATIENT ARE UNAVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 9439651 ↗