MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGA 2000 SHEATH

Model Number	0825
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burn(s) (1757); Pain (1994); Deformity/ Disfigurement (2360)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a breast implantation that the potential 0825 could be related to a burn.
Additional Manufacturer Narrative
(b)(4).Date of event: only event year known: 2022.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.No lot or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: could you please confirm if occurred a burn? if yes, 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).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 affected (patient or user)? answer: the customer did not report potential pad site burns could be related to potential no sheath use.However, a burn did occur.Two on back and one on foot.Cautery unit and pad were tested by biomed and passed.Cause unknown.Additional information received: patient sustained burns on various portions of her body and suffered disfigurement during the breast implant procedure.The complaint alleges ¿serious and disabling personal injuries.".
Additional Manufacturer Narrative
(b)(4).Date sent: 3/23/2023 photo image provided, however an evaluation is not available.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/2/2023.Please see attached op notes.
Additional Manufacturer Narrative
Pc-(b)(4).Please see attached op notes.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.

• Brand Name: MEGA 2000 SHEATH
• Common Device Name: MEGA 2000 SHEATH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): FORTUNE PLASTICS; glendale AZ 85301
• Manufacturer Contact: orla o'mahony ; 11506 south state street; draper, UT 84020
• MDR Report Key: 14575629
• Report Number: 1721194-2022-00056
• Device Sequence Number: 17403787
• Product Code: GEI
• UDI-Device Identifier: 10614559100943
• UDI-Public: 10614559100943
• Combination Product (Y/N): N
• PMA/510(K) Number: K982826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/23/2023

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
• Operator of Device: Health Professional
• Device Model Number: 0825
• Device Catalogue Number: 0825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 01/19/2023; 01/19/2023; 03/23/2023
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 02/02/2023; 02/02/2023; 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female