MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 2.5IN; E-Z CLEAN BLADE MODIFIED 2.5 INCH

Catalog Number 0012M

Device Problem Crack (1135)

Patient Problem Burn(s) (1757)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4) 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.Additional information was requested and the following was obtained: where exactly was the crack found on the device? crack was on blue insulation.How was the surgeon using the device at the time of the burn? using to open pocket on breast during a augmentation revision.What is the location and tissue layer of the burn? how was it determined to be 3rd degree? doctor said that it could develop into 3rd degree.Any pictures of the burn available for review? how was the burn identified and how was the burn treated? doctor exercised as much as burned tissue as possible.Unsure how he advised to treat after case.What is the current status of the patient? recovering.

Event Description

It was reported that during a breast augmentation the patient received a second degree burn.The burn was "half the size of a dime".Some of the area that was burned was excised and the remaining affected tissue was treated with ointment.Upon inspection the customer found that the blue insulation at the base of the electrode was cracked.The procedure was completed with a second like device.

Manufacturer Narrative

(b)(4).Date sent: 9/4/2019.Investigation summary: 14 each 0012m lot 186598 were returned for evaluation.1 each used-involved in event and 13 each new device in sealed pouches.During visual examination gouges, scratched, indentations were found in the blue insulation indicating that the electrode has come in contact with instrumentation.The likely cause of the damage is the electrode was in contact with other instruments and likely was grasped with another instrument (i.E.Hemostats).The instructions for use instruct the user to discard damaged electrodes.The other 13 each new devices were inspected and found no malfunctions and no damaged insulation.The complaint is confirmed as use related.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.

• Brand Name: E-Z CLEAN BLADE MOD 2.5IN
• Type of Device: E-Z CLEAN BLADE MODIFIED 2.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer Contact: milt garrett ; 11506 south state street; draper, UT 84020
• MDR Report Key: 8907400
• MDR Text Key: 156109318
• Report Number: 1721194-2019-00108
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559100110
• UDI-Public: 10614559100110
• Combination Product (y/n): N
• PMA/PMN Number: K081791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 0012M
• Device Lot Number: 186598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention