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

Catalog Number 0845

Device Problems Human-Device Interface Problem (2949); Appropriate Term/Code Not Available (3191)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 08/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 1/31/2024 investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number gs22008603, and no non-conformances were identified 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.Additional information was requested, and the following was obtained: is the megadyne pad currently being used in the facility.¿ megasoft pad is currently in use 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 none ¿ if yes, where are they and what is the description of the damage(s)? na are there photos that can be shared of the pad? na what is the serial number of the pad?--- lot/sn no for the megasoft 0845 is (b)(6).How long has the account been using mega soft?¿since 2 years does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? ----since surgeon was informed of burn dr felt it was pad that led to patient burn but after their biomedical engineer had informed that it was not a pad site burn when were the burns first noticed?---post op what medical intervention was used to treat the burn (such as salve or stitches)?----as per the information topical dressing and antibiotics were used where is the burn located on the patient?¿burn was located at lumbar angle region where there is gap during supine patient postion was the reported issue at the pad site or alternate site?---at hospital was reported as burn not specifically pad site or alternative site burn besides the burn, did the patient experience any adverse consequence due to the issue?----none reported are there any anticipated long-term effects from the burn or injury?--na what is the current status of the patient?---na what was the surgical procedure? ----cabg how long did the surgical procedure last?----surgery lasted for 4-5 hrs what cleaner or disinfectant (brand name or active ingredients) was used to clean the pad?-----none was the pad rinsed with water and let dry before this surgical procedure?---na how was the patient positioned?---supine position is it possible the patient was in contact with a metal portion of the or table?---no, as per there sop entire ot bed is covered via cotton cloth how was the room set up to include patient set up and where was the pad in relation to the patient?---na was there anything between patient and the pad (ex.Sheet, drape, etc.)? ---a plastic cover was used to keep pad clean over that a cotton cloth was kept before the patient were there liquids used in prep?---betadine solution was used for patient prep what skin preparation regiment was utilized for the procedure?---- betadine solution was used for patient prep was urine or other fluids detected in the field after surgery?-------na was there any patient warming blankets used? ---yes ¿ if yes, what warming device and/or blankets were used and what is the location in relation to the patient?¿regular warmer used in or was used and was kept below pad what temperature setting was used on the warming device(s)?---na what generator was being used?----medtronic force fx4 was used what power levels was generator set to? -----cut-20,coag-60 was there any diminished effect of the generator noted during the surgery?----surgeon needed to increase power level compared to use of regular sticky pads what monopolar disposables were used during the procedure? -----monopolar regular pencils were used what is the age of the patient?------na what is meant by ¿liquid burn¿? ------ the left over betadine solution/saline used during the procedure for patient prep for the surgery, drips through the gaps and settles at the gap between patient and pad at near thoracodorsal fascia what investigation was done to allow the account to believe that these are liquid burns? ---- we did entire in-service for the ot staff, surgeon and the biomedical engineer showcasing the do¿s and don¿ts for the megasoft pad with dry demonstration.What ethnicity was the patient? -----not known what is the severity of the burn? (please see degrees of burns below and choose one)------- first degree of burn as per the pictures shown and the information provided (note:- due to internal reason hospital has refused to share the pictures of the patient) what is the age of the patient? if not, was the patient an adult or pediatric.No further information has been provided.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 a cabg procedure it was suspected of pad site burn with megasoft 0845.On examination megasoft pad was functioning normally and as per the details provide the burn seems to be likely of liquid burn.

Manufacturer Narrative

(b)(4).Date sent: 2/15/2024 upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event, and is being considered not reportable.

• 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: 18617122
• MDR Text Key: 334621394
• Report Number: 1721194-2024-00008
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103906
• UDI-Public: 10614559103906
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 0845
• Device Lot Number: GS22008603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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-1998-2023
• Patient Sequence Number: 1