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 Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

It was reported that during an unknown k-9 procedure that the positioner was placed between the patient and the megasoft pad that resulted in significant burns.Cause of the burns were the result of the positioner being placed between the patient and the megasoft pad, the metal rivets of the positioner were in direct contact with the patients.

Manufacturer Narrative

(b)(4).Date sent: 12/1/2023.B3: exact date is unk.Assumed the first day of the month.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.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.Additional information received: the veterinarian was setting up the megasoft pad incorrectly.He was placing the positioning wedge on top of the pad.Not sure if the patient was shaved before or after the burn.The patient not in contact with the megasoft pad.They laid the positioner wedge on top of the megasoft pad rather than underneath it.Additional information was requested, and the following was obtained: is the megadyne pad currently being used in the facility.¿ if no, why not? yes is there any damage(s) noted on the pad? no.¿ if yes, where are they and what is the description of the damage(s)? how long has the account been using mega soft? 2 months does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? no-he is aware that the burned was caused by a user error-setting up the pad incorrectly.When were the burns first noticed? i don¿t know what is the severity of the burn? (please see degrees of burns below and choose one) i cannot make this determination.I have not seen the dogs firsthand.I uploaded photos of both dogs.¿ 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)? i don¿t know.Where is the burn located on the patient? patient one appears to have a burn on his back.Patient 2 appears to have a burn on his side.Was the reported issue at the pad site or alternate site? don¿t know besides the burn, did the patient experience any adverse consequence due to the issue? don¿t know.Are there any anticipated long-term effects from the burn or injury? don¿t know.What is the current status of the patient? don¿t know.What was the surgical procedure? veterinary-not sure what the procedure was what was the surgical procedure date? mid october, 2023.How long did the surgical procedure last? don¿t know.What cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? don¿t know.Was the pad rinsed with water and let dry before this surgical procedure? don¿t know how was the patient positioned? don¿t know.Is it possible the patient was in contact with a metal portion of the or table? yes-patient was in contact with the metal rivets on the patient positioner pad.How was the room set up to include patient set up and where was the pad in relation to the patient? i upload photos on how they set it up incorrectly.Was there anything between patient and the pad (ex.Sheet, drape, etc.)? yes- a towel and a patient positioner were placed on top of the megasoft pad.Were there liquids used in prep? don¿t know.What skin preparation regiment was utilized for the procedure? don¿t know.Was urine or other fluids detected in the field after surgery? don¿t know.Was there any patient warming blankets used? don¿t know.¿ 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)? don¿t know.What generator was being used? don¿t know.What power levels was generator set to? don¿t know.Was there any diminished effect of the generator noted during the surgery? don¿t know.What monopolar disposables were used during the procedure? don¿t know.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).Date sent: 12/18/2023.Photo analysis: this is an analysis of an image submitted for evaluation.The photo shows one side of a dog back.There is a strip shape of skin burn within a large shaved area.The affected skin appears red mixed with dark red and charring spots.No blisters or significant swelling were observed.The skin damage was most likely a second-degree burn.The reported event was confirmed.However, no conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.

• 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 ; PR ; 3035526892
• MDR Report Key: 18246340
• MDR Text Key: 329483861
• Report Number: 1721194-2023-00135
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103906
• UDI-Public: 10614559103906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• 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: 12/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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