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

Catalog Number	0846
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Following information was requested but unavailable: are there photos available for review? was a compatibility table being used? if so, which one? where was the pad in relations to the body hugger? how is the pad cleaned?.
Event or Problem Description
It was reported that post op of an aorto bi-femoral bypass, on the back of the patient a burn was noticed.Unknown exactly if the pad was the cause of the burn to the patient.Patient was noticed to have extensive first and second degree burns on patients entire back.They were using both an under body and over body bear hugger, which both tested fine for the biomed.The biomed said they used two coviden esus as well.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/13/2019.Additional information: after this event, the account performed testing of various scenarios including dermatological to determine what might have caused the burn.After testing, they traced/linked the burn to a chemical burn and not from the megasoft pad.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/27/2019.Upon review of the information provided, it was concluded that the device in this event did not malfunction or cause the reported event.Therefore does not meet the fda defined criteria for a reportable event.

• 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: 8318359
• Report Number: 1721194-2019-00078
• Device Sequence Number: 2285383
• Product Code: GEI
• UDI-Device Identifier: 10614559104248
• UDI-Public: 10614559104248
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2019

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: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 0846
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 01/11/2019; 01/11/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 02/13/2019; 02/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other