NA 2841-12-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295155027), received between Aug 17, 2017 and Aug 17, 2017 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HOOK-AND-LOOP FASTENERS WERE PACKAGED WITH THE WRONG IFUS. IT IS ALSO REPORTED THAT THE PRODUCT IS A ONE-TIME USE PRODUCT HOWEVER THE IFU IS FOR A REUSABLE DEVICE. THE PRODUCT LABELING IS CORRECT.

  Patient problems: No Information

  MAUDE report 6800744 ↗
• MalfunctionAug 17, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HOOK-AND-LOOP FASTENERS WERE PACKAGED WITH THE WRONG IFUS. IT IS ALSO REPORTED THAT THE PRODUCT IS A ONE-TIME USE PRODUCT HOWEVER THE IFU IS FOR A REUSABLE DEVICE. THE PRODUCT LABELING IS CORRECT.

  Patient problems: No Information

  MAUDE report 6800740 ↗