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

Catalog Number	0845
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 12/15/2023.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.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 was requested, and the following was obtained: is the megadyne pad currently being used in the facility.If no, why not? 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.Is there any damage(s) noted on the pad? if yes, where are they and what is the description of the damage(s)? are there photos that can be shared of the pad? if yes, please send to productcomplaint1@its.Jnj.Com.What is the serial number of the pad? how long has the account been using mega soft? does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? what is the severity of the burn? (please see degrees of burns below and choose one) 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)? was the reported issue at the pad site or alternate site? besides the burn, did the patient experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? what is the current status of the patient? how long did the surgical procedure last? what cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? was the pad rinsed with water and let dry before this surgical procedure? how was the patient positioned? is it possible the patient was in contact with a metal portion of the or table? how was the room set up to include patient set up and where was the pad in relation to the patient? was there anything between patient and the pad (ex.Sheet, drape, etc.)? were there liquids used in prep? what skin preparation regiment was utilized for the procedure? was urine or other fluids detected in the field after surgery? 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? what temperature setting was used on the warming device(s)? what generator was being used? what power levels was generator set to? was there any diminished effect of the generator noted during the surgery? what monopolar disposables were used during the procedure? what is the age of the patient? if the age of the patient is not known, is the patient an adult or pediatric patient? what ethnicity is the patient? answer: it was not the megasoft pad - but the sticky pad that caused the burn.The sticky pad was on the right side hip/back area.The megasoft pad was laid flat directly under the table.There was 2 generators being used.It was a third degree burn.Additional information was requested, and the following was obtained: was dual generators being used? answer: there were dual generators being used.The sticky pad in one generator and the megasoft pad in another generator.The sticky pad likely caused the burn.From my findings, here is what i know - ¿ the burn was on the patient's right hip, slightly above the waistline.The sticky pad was placed on the right side of the lower back.O i was able to obtain a picture of the burn if you would like me to send that to you.¿ i have not spoken directly to the surgeon.This decision was based on the clinical conversation between the operating room manager and the nurse's line.¿ the rationale behind this decision was based on the findings that when using the megasoft pad, the current does not run through the patient.However, the current runs through the patient when using a sticky pad.Although not certain, it was communicated the sticky pad could have lifted because of the placement on the patient.¿ there has been no follow-up based on treatment.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 or Problem Description
It was reported that during a bilateral breast reduction, there was a megasoft pad used.There was a staple on the drape on the patients right hip.After the procedure a burn was noticed on the patient right hip.The burn is the same size as skin staple.The tissue color is blackish brown.At the time of the call it was unknown how the patient was treated for the burn.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/4/2024.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Photo analysis: this is an analysis of an image submitted to for evaluation.Photo of the patient's right buttock area (based on the description of the incident) were submitted for evaluation.It's unclear when the photo was taken.A slightly dented and charred burn area in its healing process is visible in the photo.There were no other abnormalities visible in the surrounding skin.Based on its appearance, it looks like a third-degree burn.No conclusion could be reached as to how this issue occurred through photo analysis.(b)(6) is not a valid serial number and was removed from the file.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/14/2024.

• Brand Name: MEGASOFT UNIVERSAL
• Common Device Name: 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 ; PR ; 3035526892
• MDR Report Key: 18334075
• Report Number: 1721194-2023-00140
• Device Sequence Number: 8425003
• Product Code: GEI
• UDI-Device Identifier: 10614559103906
• UDI-Public: 10614559103906
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0845
• Device Lot Number: 0845M2K08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 03/01/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/04/2024; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1998-2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown