Megadyne 0855CNRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10614559104613), received between Nov 12, 2018 and Mar 25, 2025 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2025Use of Device Problem; Use of Device Problem

  PER USER FACILITY MEDWATCH FORM, #MW5166185 AND MW5166186, DURING AN UNKNOWN PROCEDURE; THE MEGADYNE PAD CONNECTED TO ERBE MACHINE PRIOR TO A GI PROCEDURE REQUIRING HOT SNARE POLYP REMOVAL. THE ERBE MACHINE DID NOT REGISTER THE PAD AS CONNECTED. THE PAD WAS REMOVED FROM PATIENT AND A NEW PAD WAS APPLIED TO PATIENT AND AGAIN CONNECTED TO ERBE MACHINE. THE SECOND PAD APPLIED DID NOT REGISTER WITH THE ERBE MACHINE. THE PROVIDER HAD TO CONVERT THE PROCEDURE TO A COLD SNARE. NO PATIENT HARM WAS REPORTED. DEVICE WAS AVAILABLE FOR RETURN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686917 ↗
• InjuryMar 25, 2025Use of Device Problem; Use of Device Problem

  PER USER FACILITY MEDWATCH FORM, #MW5166185 AND MW5166186, DURING AN UNKNOWN PROCEDURE; THE MEGADYNE PAD CONNECTED TO ERBE MACHINE PRIOR TO A GI PROCEDURE REQUIRING HOT SNARE POLYP REMOVAL. THE ERBE MACHINE DID NOT REGISTER THE PAD AS CONNECTED. THE PAD WAS REMOVED FROM PATIENT AND A NEW PAD WAS APPLIED TO PATIENT AND AGAIN CONNECTED TO ERBE MACHINE. THE SECOND PAD APPLIED DID NOT REGISTER WITH THE ERBE MACHINE. THE PROVIDER HAD TO CONVERT THE PROCEDURE TO A COLD SNARE. NO PATIENT HARM WAS REPORTED. DEVICE WAS AVAILABLE FOR RETURN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686872 ↗
• MalfunctionOct 30, 2023Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MEGADYNE DISPERSIVE RETURN ELECTRODES ARE HAVING CHALLENGES, AS THE GEL OF THE ELECTRODE IS ATTACHED TO THE PATIENT'S SKIN AND SURGICAL CLOTHING, ADDITIONAL LEAVES SKIN SENSITIVITY TO THE PATIENT AT THE TIME OF REMOVAL. THE PATIENT DID NOT HAVE BURNS, IT IS ONLY SENSITIVITY. TO CLARIFY WHAT HAPPENS WITH THE PRODUCT, IS THAT THE GEL OF THE ELECTRODE WHEN REMOVED FROM THE PATIENT REMAINS ADHERES TO THE SURGICAL UNIFORM, GLOVES AND SKIN OF THE PATIENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18030153 ↗
• MalfunctionJan 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT POST-OP TO THE UNKNOWN PROCEDURE THAT AFTER THE PROCEDURE THE GROUNDING PAD WAS REMOVED. THE REGISTERED NURSE NOTED SKIN IRRITATION. PATIENT EVENTUALLY HAD NOTICEABLE BRUISING AND REDNESS. THE SKIN WAS STILL INTAKE AND PAIN FREE. THE EFFECTIVE AREA WAS ON THE OUTER SIDE AND ROUGHLY SIX INCHES IN LENGTH. UNKNOWN OF THE CURRENT CONDITION OF THE PATIENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16157716 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE POSTERIOR SPINAL FUSION PROCEDURE, THAT DURING A C2-T4 POSTERIOR CERVICAL FUSION, NERVE MONITORING NEEDLES WERE PLACED IN THE PATIENTS SHIN, CALF, AND FEET MUSCLES, AS WELL AS THE HANDS. AT THE COMPLETION OF THE PROCEDURE, PERCEIVED BURN MARKS WERE NOTED ON THE PATIENTS FEET AND LEGS AT THE NERVE MONITORING NEEDLE SITES. NO BURNS WERE NOTED AT THE HANDS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE PATIENT CONSEQUENCES.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 14853200 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE POSTERIOR SPINAL FUSION PROCEDURE, THAT DURING A C2-T4 POSTERIOR CERVICAL FUSION, NERVE MONITORING NEEDLES WERE PLACED IN THE PATIENTS SHIN, CALF, AND FEET MUSCLES, AS WELL AS THE HANDS. AT THE COMPLETION OF THE PROCEDURE, PERCEIVED BURN MARKS WERE NOTED ON THE PATIENTS FEET AND LEGS AT THE NERVE MONITORING NEEDLE SITES. NO BURNS WERE NOTED AT THE HANDS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE PATIENT CONSEQUENCES.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 14853198 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PATIENT EXPERIENCED A RADIOFREQUENCY BURN AT PAD SITE.

  Patient problems: Pain; Partial thickness (Second Degree) Burn

  MAUDE report 13901372 ↗
• MalfunctionDec 16, 2021Energy Output Problem

  PHYSICIAN REPORTED FEELING ENERGY WHILE USING A MEGADYNE BOVIE CAUTERY. BOVIE PADS CHANGED FROM MEGADYNE TO 3M BRAND AND ISSUE WAS RESOLVED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026126 ↗
• MalfunctionMay 24, 2021Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PATIENT STATED PRIOR TO HAVING SURGERY THAT SHE HAD VERY DELICATE SKIN AND THAT ON A PRIOR SURGERY SHE HAD A LARGE SKIN TEAR POST OP FROM THE SURGICAL DRAPES. DOCTOR WAS MADE AWARE OF THIS INFORMATION. GREAT CARE WAS TAKEN IN DRAPING THE PATIENT. A BOVIE PAD WAS PLACED ON THE RIGHT THIGH. THE BOVIE PAD (MEGADYNE) CURRENTLY BEING USED IN SURGICAL DEPARTMENT IS NOT THE USUAL COVIDIEN PAD THAT IS NORMALLY USED. THE COVIDIEN PADS ARE ON BACKORDER. AT THE END OF THE PROCEDURE, DOCTOR CAREFULLY REMOVED THE STERILE DRAPES WITHOUT A SKIN TEAR TO THE PATIENT. DOCTOR THEN ATTEMPTED TO REMOVE THE BOVIE PAD CAREFULLY AND THE PATIENT ENDED UP RECEIVING A 1" SKIN TEAR. THE AREA OF SKIN TEAR WAS IMMEDIATELY DRESSED WITH A TEGADERM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871712 ↗
• MalfunctionOct 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER AN UNKNOWN PROCEDURE, THE PATIENT DEVELOPED CONTACT DERMATITIS FROM THE BOVIE GROUNDING PAD ADHESIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10762689 ↗
• MalfunctionJul 27, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HOSPITAL WAS DOING A TRIAL ON MEDADYNE BOVIE PADS INTRA-OP. THE PATIENT HAD THE BI-LATERAL BOVID PADS ON. AT THE CONCLUSION OF THE SURGERY, THE BOVIE PADS WERE REMOVED AND THE PATIENT HAD DEVELOPED BILATERAL PINPOINT BRUISING MARKS AT THE SITE AND SHAPE OF BOVIE PADS THAT WERE USED DURING THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10325999 ↗
• MalfunctionJul 27, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HOSPITAL WAS DOING A TRIAL ON MEDADYNE BOVIE PADS INTRA-OP. THE PATIENT HAD THE BI-LATERAL BOVID PADS ON. AT THE CONCLUSION OF THE SURGERY, THE BOVIE PADS WERE REMOVED AND THE PATIENT HAD DEVELOPED BILATERAL PINPOINT BRUISING MARKS AT THE SITE AND SHAPE OF BOVIE PADS THAT WERE USED DURING THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10325982 ↗
• MalfunctionApr 1, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A PLASTIC SURGERY, WHEN THE PAD WAS REMOVED FROM THE PATIENT, THERE WAS SOME REDNESS/BRUISING AND SWELLING. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913526 ↗
• InjuryMar 5, 2019Residue After Decontamination

  IT WAS REPORTED THAT AFTER AN UNKNOWN PROCEDURES THAT THE CUSTOMER HAS STATED THEY ARE HAVING NUMEROUS ISSUES WITH GROUNDING PAD FROM MEGADYNE LEAVING STICKY RESIDUE BEHIND, CAUSING BRUISING UPON REMOVAL AND SKIN DENUDING OF PATIENTS WHERE PAD HAS BEEN PLACED. BRUISING/SKIN DENUDING DUE TO ADHESIVE. CUSTOMER DID SHARE THAT THEY SLOWLY REMOVED THE PAD, USING DIFFERENT TECHNIQUE AND IT APPEARED THAT BY GOING SLOWER IT DREW MORE BLOOD TO TOP OF SKIN CAUSING MORE OF A HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 8391769 ↗
• MalfunctionNov 12, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT POST OP OF AN UNKNOWN PROCEDURE, MEGADYNE PAD 0855CN LEFT A RED IRRITATION PERIMETER LINE ON THE RIGHT LEG OF THE PATIENT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED, OR IF THE CASE WAS COMPLETED WITH THE SAME PAD. IT IS UNKNOWN IF THERE WERE ANY ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8061865 ↗