WasherLoc™ 908648Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304410732), received between Jan 27, 2022 and Mar 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMar 1, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE SLEEVE INSIDE OF THE STERILE POUCH WAS FOUND DAMAGED. THERE WAS NO BACKUP PRODUCT TO USE INSTEAD, SO THE SURGEON USED THE SAME DEVICE TO SUCCESSFULLY COMPLETE THE SURGERY. PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636129 ↗
• MalfunctionJan 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING WAS DAMAGED. THE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13369013 ↗