Megadyne 0865CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10614559102770), received between Aug 14, 2019 and May 10, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Overheating of Device” (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.

• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING EXTERNAL GENITAL PROCEDURE, THE SURGICAL FIELD WAS A TIGHTLY DEFINING AREA TO BE OPERATED . TWO BURN-LIKE LESIONS WERE DISCOVERED WHEN REMOVING OF THE FIELDS. IT WERE SIMILAR IN SIZE AND SHAPE TO THE TIP OF THE ELECTRIC SCALPEL, UNDER THE FIELDS, AT A LENGTH FROM THE OPERATING SITE, ON THE INNER SIDE OF THE THIGH AND THE ILIAC WING. THE LESIONS WERE COVERED BY SKIN GLUE. ESTIMATED BURN GRADE 2 SUPERFICIAL. THE LESIONS WILL BE SCARRED, WHICH MAY PRODUCE SKIN MARKS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 14345325 ↗
• InjuryAug 14, 2019Overheating of Device

  IT WAS REPORTED THAT POST OP OF AN UNKNOWN PROCEDURE, IT IS UNKNOWN WHAT OCCURRED POSSIBLE OVERHEATING OF THE PAD. THE PATIENT HAS A BURN AND A SCAR FROM THE PAD. IT IS UNKNOWN HOW THE PATIENT WAS TREATED.

  Patient problems: Burn(s)

  MAUDE report 8894075 ↗