MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. BIPOLAR CABLE FLY LD GEN PLUG; BIPOLAR CABLE FLYING LEAD 12 FEET (3.7 M)

Catalog Number	4000J
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2018
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: the account buys bulk non-sterile devices, med line sterilizes them and then put them into custom kits.The device used in this event was from a custom kit.
Event or Problem Description
It was reported that the doctor performed a craniotomy on a patient and after the procedure, the patient returned with an infection.It was not reported how the infection was treated.

• Brand Name: BIPOLAR CABLE FLY LD GEN PLUG
• Common Device Name: BIPOLAR CABLE FLYING LEAD 12 FEET (3.7 M)
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 7975951
• Report Number: 1721194-2018-00048
• Device Sequence Number: 1195394
• Product Code: GEI
• UDI-Device Identifier: 10614559105764
• UDI-Public: 10614559105764
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K982748
• 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
• Report Date (Section B): 09/17/2018

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: Health Professional
• Device Catalogue Number: 4000J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other