Megadyne 0313Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10614559101551), received between Jun 7, 2018 and Jun 7, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2018Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE UPON OPENING THE DEVICE WHICH SHOULD HAVE HAD PART NUMBER 0313 INSTEAD HAD 0313M INSIDE. TWO OTHER DEVICES WERE OPENED WITH THE SAME INCORRECT 0313M PART INSIDE. AN ALTERNATE LOT# WITH THE CORRECT PART INSIDE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7579563 ↗
• MalfunctionJun 7, 2018Packaging Problem

  IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE UPON OPENING THE DEVICE WHICH SHOULD HAVE HAD PART NUMBER 0313 INSTEAD HAD 0313M INSIDE. TWO OTHER DEVICES WERE OPENED WITH THE SAME INCORRECT 0313M PART INSIDE. AN ALTERNATE LOT# WITH THE CORRECT PART INSIDE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7579542 ↗
• MalfunctionJun 7, 2018Packaging Problem

  IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE UPON OPENING THE DEVICE WHICH SHOULD HAVE HAD PART NUMBER 0313 INSTEAD HAD 0313M INSIDE. TWO OTHER DEVICES WERE OPENED WITH THE SAME INCORRECT 0313M PART INSIDE. AN ALTERNATE LOT# WITH THE CORRECT PART INSIDE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7579521 ↗