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

Catalog Number 0846

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

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/10/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/14/2023 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.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: what is the severity of the burn? (please see degrees of burns below and choose one) o 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 o second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful o 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) 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? answer = patient position- supine.Placement of megasoft- flat on the ot table.Layers between patient & megasoft- linen sheet (soiled with water during the procedure) patient age ¿ 11 yrs, weight- ~30kgs.Examination- histopath procedure, lap procedure converted to open, there was spillage during the procedure.Patient outcome- burn on the left side of the back.Cautery machine- valleylab.Megasoft connecting wires- no damage.Megasoft pad- no damage or burn found.Cleaning solution- betadine , no pooling reported.Cautery pencil- covidien.The hospital doesn¿t want to share any details pertaining to the burn or share the picture.No other adverse consequence shared by them.Additional information was requested, and the following was obtained: is the megadyne pad currently being used in the facility.If no, why not?- yes it is being used.Are there any photos of the burn (s) that you could share with us in regards to the burn? - no.What is the serial number of the pad?- not received.How long has the account been using mega soft? 6 months.Does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? ¿ could be, cause not known.When were the burns first noticed? back, where the pad was placed.What is the severity of the burn? (please see degrees of burns below and choose one)- unknown.What medical intervention was used to treat the burn (such as salve or stitches)?-unknown.Where is the burn located on the patient?- back.Was the reported issue at the pad site or alternate site? - 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?- unknown.What is the current status of the patient?- unknown.What was the surgical procedure? ¿ paed procedure.What was the surgical procedure date? ¿ (b)(6), 2023.How long did the surgical procedure last? - unknown.What cleaner or disinfectant (brand name or active ingredients) was used to clean the pad?- water.Was the pad rinsed with water and let dry before this surgical procedure? - yes.How was the patient positioned? ¿ supine, details shared earlier.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? - back.Was there anything between patient and the pad (ex.Sheet, drape, etc.)? ¿ 2 linen, details already shared.Were there liquids used in prep?- chlorhexidine.What skin preparation regiment was utilized for the procedure? - chlorhexidine.Was urine or other fluids detected in the field after surgery?- no.Was there any patient warming blankets used? - no.If yes, what warming device and/or blankets were used and what is the location in relation to the patient?- no.What generator was being used?- valley lab.What power levels was generator set to? - unknown.Was there any diminished effect of the generator noted during the surgery?- no.What monopolar disposables were used during the procedure? ¿ valley lab what is the age of the patient?- 11 yrs.Is there any damage(s) noted on the pad? no damage.Event date: (b)(6) 2023.Additional information received: the customer indicated that there was a sheet between the patient and the pad, the pad was cleaned with saline, and the burns were discovered immediately after the surgery.Photo images photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.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 suffered a burn due to megasoft.The procedure was successfully completed.There was a patient burn.

Manufacturer Narrative

(b)(4).Date sent: 8/22/2023.Photo analysis: this is an analysis of an image submitted to for evaluation.The evaluated photo is the lower waist and both buttocks.It was taken from a pediatric patient who underwent cystoscopy and perineal urethrostomy on (b)(6) 2023.Irregular strip burn is seen in the left lower waist level.Burns appear as charred skin.No significant skin swelling or blisters were observed.The surrounding skin area appears intact.The degree of skin burns was second degree.The cause of the burns is not yet known.No conclusion could be reached as to how this issue occurred through photo analysis.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 UNIVERSAL DUAL
• Type of Device: MEGA SOFT UNIVERSAL DUAL
• 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: 17543061
• MDR Text Key: 321096552
• Report Number: 1721194-2023-00103
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559104248
• UDI-Public: 10614559104248
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 08/22/2023

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 Catalogue Number: 0846
• Device Lot Number: GS22023201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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-2001-2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Sex: Male