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

Catalog Number	0846
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.Additional information obtained: describe the pad and patient position in the surgery procedure? supine, for cabg procedure in relation to the patient, what was the anatomical position of the rigid corner of the mega soft pad? covering the shoulders beneath the patient.What was the alignment of the pad and cord relative to the surgical site? (e.G.Was the corded side of the pad facing away from the surgical site?) since it was dual cord megasoft both the cords were connected to separate electrocautery generator on either side of the patient towards the head end.Was there anything between the pad and the patient? yes one normal draping linen between patient and the pad.Was there any patient positioning tools or aides used? if so, was the pad place above or below? yes a bandaged cushioning pad placed beneath the shoulders to lift the chest which is in between linen and patient body.How was the burn identified? the burn was identified second day of the operation as noticed by the attending nurse how was the burn treated? applied bactigras's ointment is the customer alleging that this burn is potentially associated with the use of the mega soft pad? if so, why? yes.As this incidence happened within few days after megasoft was installed in or what is the current patient status? patient is to come back for follow ups after being discharged from the hospital.
Event or Problem Description
It was reported that a few days after a cabg procedure, there was a patient burn injury where the megasoft pad was used.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/18/2018.Additional information: an image was provided by the customer is that of a patient where it appears that there is damage epidermis below his shoulder.The damage to the tissue does not appear to be damaged caused by an electro surgical activation.Because the instrument was not return our evaluation is limited.

• Brand Name: MEGASOFT UNIVERSAL DUAL
• Common Device Name: MEGA SOFT UNIVERSAL DUAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8002360
• Report Number: 1721194-2018-00051
• Device Sequence Number: 203046
• Product Code: GEI
• UDI-Device Identifier: 10614559104248
• UDI-Public: 10614559104248
• Combination Product (Y/N): N
• PMA/510(K) Number: K133726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 0846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other