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 10/12/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 10/23/2023 b3: unknown; captured as awareness date.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.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.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: it is stated ¿burns in the same region¿ does that mean same region of the pad or same region of the patient? can more information be provided on the thermal mattress.Name brand of the thermal mattress.Product code of the thermal mattress.Picture of the thermal mattress.Size and thickness of thermal mattress.Can you please provide photos of the thermal mattress? send to productcomplaint1@its.Jnj.Com.Please provide photos of the tradition set up with the pad and the thermal mattress.Was a draw sheet between thermal mattress and the patient.How are you cleaning the pad and the thermal mattress? please provide the name of the cleaner used.Are you rinsing the pad and thermal mattress and letting it dry before use? are you investigation other potential causes of the burns to include the thermal mattress? is the megadyne pad currently being used in the facility.If no, why not? 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.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? could you please re-confirm 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? 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? 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? 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? what ethnicity is the patient? 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 unknown procedure the patient presented burns.I emphasize that this mattress is often used in other surgeries and that before the acquisition of the megadyne plate we had no burn incident.After using this megadyne plate we have a burn incident.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Date sent: 12/7/2023.Photo analysis: this is an analysis of an image submitted for evaluation.Photo of the patient's buttocks was evaluated.There were significant thermal injuries on both sides of the buttocks.The affected area of skin is bright red with small blisters on the left side.The out edges of redness area is uneven, with some small area unaffected.There was no skin breakdown visualized.The thermal injuries appeared to be second-degree burns, but the cause of the injuries could not be determined based on the photos.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 ; 3035526892
• MDR Report Key: 17985130
• MDR Text Key: 326266127
• Report Number: 1721194-2023-00122
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103906
• UDI-Public: 10614559103906
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K133726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 0845
• Device Lot Number: GS21017071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 12/07/2023; 12/11/2023
• Supplement Dates FDA Received: 12/07/2023; 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2021
• 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