MAUDE Adverse Event Report: ETHICON, INC./MEGADYNE MEDICAL PRODUCTS, INC. ETHICON MEGADYNE GEL MAT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0846

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 04/21/2023

Event Type  Injury  

Event Description

Reporter calling to report an adverse event.Reporter states that on (b)(6) 2023, a five year old female patient had a procedure to remove her tonsils and adenoids.After the procedure, patient was discharged to home under the care of her mother; the patient was bathed at home by her mother on the evening of (b)(6) 2023.Patient's mother called the clinic back on (b)(6) 2023 after noticing her daughter had "burn-like wounds to her bottom." reporter states the clinic directed the mother to immediately bring the patient in to see the wound clinic for evaluation.Mother complied and on (b)(6) 2023 the patient was diagnosed with second and third degree burns.Reporter states that after learning of the patient's burns, a debrief of the previous surgical procedure was performed to identify any potential problems.Reporter states that operating room staff recalled that the patient "urinated right after being intubated." reporter states that operating room staff cleaned the patient, however were unable to clean the contact surface between the patient and the megadyne mat.Reporter also states that after cleaning up the patient, "clean, dry sheets" were placed "between" the patient and the megadyne prior to beginning the procedure.

• Brand Name: ETHICON MEGADYNE GEL MAT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON, INC./MEGADYNE MEDICAL PRODUCTS, INC.
• MDR Report Key: 16815904
• MDR Text Key: 314021139
• Report Number: MW5117032
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 0846
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Sex: Female