MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. PNCL 12 USE RKR HLSTR 10FT CORD; PENCIL 12 USE ROCKER HOLSTER 10 FT CORD

Catalog Number	3030H
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported during an unknown procedure the patient received two burns on either side of the incision.The burns were not life threatening and it is unknown how the burns were treated.It is unknown how the procedure was completed.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/20/2019.Additional information: upon review of the reported event and additional information obtained during investigation, it was determined that this was a 2nd degree burn and they only used topical cream to facilitate healing.Therefore, this event does meet the fda defined criteria of serious injury and being considered a malfunction.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/25/2019.Investigation summary: one each 3030h lot number unknown.The device was functionally tested and found within specifications.Complaint is unconfirmed.The lot was not provided; therefore, the manufacturing records could not be reviewed.

• Brand Name: PNCL 12 USE RKR HLSTR 10FT CORD
• Common Device Name: PENCIL 12 USE ROCKER HOLSTER 10 FT CORD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8395877
• Report Number: 1721194-2019-00086
• Device Sequence Number: 13513107
• Product Code: GEI
• UDI-Device Identifier: 10614559102527
• UDI-Public: 10614559102527
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K050102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2019

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 Catalogue Number: 3030H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/07/2019; 02/07/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/20/2019; 03/25/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEGAPOWER 1000 A GENERATOR, REUSEABLE PAD
• Outcome Attributed to Adverse Event: Other