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

Catalog Number 0840

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

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

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 4/29/2024, from form 806.10: 1721194-04.30.2024-001-r.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Photo analysis: a single photo of the bilateral buttocks of a pediatric patient related to this file is available for evaluation.Thermal burns to the skin are visible on both sides of the buttocks.The burn on the left buttock was in the shape of a rectangle extending from top to bottom.Affected areas of skin appear charring and may have blisters.Skin burns on the left buttock is a second to third degree burn.It is worth noting that thermal burns on the left side have mesh marks inside of the burn area and clear borders.The burn on the right buttock was oval to round in shape.There are visible mesh marks within the affected area of skin.Although some skin is charred, no blisters are visible in the burned area.The burns on the right side appear to be second degree burn.Serial number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information received: our team has conducted an investigation at the center, but we have not yet determined the root cause of the burns.We, along with the hospital¿s operating room team, are confident that the incident is not related to the pad itself, knowing that they have been using the device in the center for 14 years and never experienced an incident related to the pad.Additional information was requested, and the following was obtained: product code: 0840 - (b)(6).Is the megadyne pad currently being used in the facility.If no, why not? yes.Are there any photos of the burn (s) that you could share with us in regards to the burn? if yes, please send to productcomplaint1@its.Jnj.Com: yes- photos will be e-mailed.Is there any damage(s) noted on the pad? if yes, where are they and what is the description of the damage(s)? no.Are there photos that can be shared of the pad? if yes, please send to productcomplaint1@its.Jnj.Com: yes- photos will be e-mailed.What is the serial number of the pad? (b)(6).How long has the account been using mega soft? since 2010.Does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? no.When were the burns first noticed? at the ward.What is the severity of the burn? (please see degrees of burns below and choose one) first degree.First degree burns are minor burns on the first layer of skin.The skin looks dry, redness, and may be swelling; no penetration or blisters.Second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful.Third degree burn the burn site looks deep, whitening or blackened and charred what medical intervention was used to treat the burn (such as salve or stitches)? salve was the reported issue at the pad site or alternate site? at the pad site besides the burn, did the patient experience any adverse consequence due to the issue? no.Are there any anticipated long-term effects from the burn or injury? no.What is the current status of the patient? treated.He¿s okay.What was the surgical procedure? appendectomy.What was the surgical procedure date? (b)(6) 2024.How long did the surgical procedure last? 1hr 30min.What cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? disinfectant spray (ingredients and brand not specified).Was the pad rinsed with water and let dry before this surgical procedure? how was the patient positioned? it was dry.Is it possible the patient was in contact with a metal portion of the or table? no.How was the room set up to include patient set up and where was the pad in relation to the patient? it was not in indirect contact with the patient and chosen according to the weight of the patient.Was there anything between patient and the pad (ex.Sheet, drape, etc.)? sheet.Were there liquids used in prep? iodine.What skin preparation regiment was utilized for the procedure? iodine.Was urine or other fluids detected in the field after surgery? no.Was there any patient warming blankets used? if yes, what warming device and/or blankets were used and what is the location in relation to the patient? no.What temperature setting was used on the warming device(s)? not used.What generator was being used? bowa.What power levels was generator set to? 15-20.Was there any diminished effect of the generator noted during the surgery? no.What monopolar disposables were used during the procedure? covidien monopolar.What is the age of the patient? if the age of the patient is not known, is the patient an adult or pediatric patient? 12 years.What ethnicity is the patient? saudi.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: for file it was stated that the patient suffered from a 1st degree burn and was treated with salve.Was the salve over the counter medication? what is the correct event date? was this salve doctor prescribed medication? also it was stated that there were photos.Please send the photos to productcompliant1@its.Jnj.Com.The additional information states ¿product code: 0840 ¿ serial number (b)(6)¿.However, according to our external manufacturer, the serial number in the file, (b)(6), is for an 0830 pad.Each pad has a unique serial number.It is important that we have correct information for this file.Please provide the correct product code for file (b)(4).Please provide the correct serial number for file (b)(4).Also, the product code pad 0840 has a 50-lb maximum weight limit.What is the age of the patient for file? what is the weight of the patient for file? 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.

Event Description

It was reported that during an appendectomy the patient's buttocks were burned after the operation was completed.

Manufacturer Narrative

(b)(4).Date sent: 5/7/2024 additional information was requested, and the following was obtained: o it was stated that the patient suffered from a burn and was treated with salve.Was the salve over the counter medication? no o was this salve doctor prescribed medication? yes the additional information states ¿product code: 0840 ¿ serial number (b)(6)¿.However, according to our external manufacturer, the serial number in the file, (b)(6), is for an 0830 pad.Each pad has a unique serial number.It is important that we have correct information for this file.Please provide the correct product code for file (b)(4).0830 please provide the correct serial number for file (b)(4).(b)(6).Also, the product code pad 0840 has a 50-lb maximum weight limit.What is the age of the patient for file (b)(4)? 12 years.O what is the weight of the patient for file (b)(4)? more than 23 kg.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.

Manufacturer Narrative

(b)(4) date sent: 5/9/2024.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Because the instrument was not returned our evaluation is limited.

• Brand Name: MEGASOFT PEDIATRIC
• Type of Device: MEGA SOFT PEDIATRIC
• 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 ; PR ; 3035526892
• MDR Report Key: 19205636
• MDR Text Key: 341311816
• Report Number: 1721194-2024-00049
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103395
• UDI-Public: 10614559103395
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K080741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0840
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2024
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Weight: 23 KG