MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT UNIVERSAL; MEGA SOFT UNIVERSAL

Catalog Number 0845

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that during an abdominoplasty a patient has suffered some burns on the back after a 5 hour surgery.

Manufacturer Narrative

(b)(4).Date sent: 10/17/2023.B3: only event year known: 2023.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.No serial number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: what is the procedure name? ¿ extended brachioplasty, abdominoplasty, removal of right cyst in neck.How long has the account been using mega soft? - years.Does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? - no.Could you please clarify the severity of the burn? second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful.What medical intervention was used to treat the burn (such as salve or stitches)? ¿ saline & dressing.Was the reported issue at the pad site or alternate site? ¿ pad site.Did the patient experience any other adverse consequence due to the issue besides the burn? - no.Are there any anticipated long-term effects from the burn or injury? ¿ burn marks.What is the current status of the patient? ¿ wound is dry.What was the cleaning procedure used for the mega soft mats? what cleaner or disinfectant (brand name or active ingredients) was used? ¿ neutral detergent.Was the pad rinsed with water and let dry before this surgical procedure? - no.Was the patient in contact with any device during procedure? is it possible the patient was in contact with a metal portion or table? - no.How was the room set up to include position of patient and where was the pad in relation to the patient? ¿ pad, draw sheet and patient.What procedure prep was used? were there liquids used in prep? - betadine.What skin preparation regiment was utilized for the procedure? - no.Was urine or other fluids detected in the field after surgery? - no.What generator was being used? - megadyne.What power levels was generator set to? ¿ 30-60.Was there any diminished effect of the generator noted during the surgery? - no.What monopolar disposables were used during the procedure? ¿ diathermy pencil, forceps.What is the age & ethnicity of the patient? ¿ white female.Are there better photos of the burn on the patient? the other photos were blurry.Was there any material (draw sheet) between the patient and the pad? yes.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Photo summary: this is an analysis of an image submitted for evaluation.The image is of poor quality.Given those limitations, it appears to demonstrate a burn to the upper back.It is difficult to determine the degree of the burn due to the image quality.No conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.

Manufacturer Narrative

(b)(4).Date sent: 3/14/2024.

• Brand Name: MEGASOFT UNIVERSAL
• Type of Device: MEGA SOFT UNIVERSAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17950628
• MDR Text Key: 325899096
• Report Number: 1721194-2023-00120
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103906
• UDI-Public: 10614559103906
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1998-2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White