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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. NON COATED PNCL BTN HLSTR; NON COATED PENCIL BUTTON HOLSTER
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MEGADYNE MEDICAL PRODUCTS, INC. NON COATED PNCL BTN HLSTR; NON COATED PENCIL BUTTON HOLSTER Back to Search Results
Catalog Number 0039H
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Sent: 10/22/2019/ date of event is unknown/ batch # unknown/ the lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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.
 
Event or Problem Description
It was reported that during a hernia procedure there was a flash at the surgical site.No adverse consequences for the patient reported.
 
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Brand Name
NON COATED PNCL BTN HLSTR
Common Device Name
NON COATED PENCIL BUTTON HOLSTER
Manufacturer (Section D)
MEGADYNE MEDICAL PRODUCTS, INC.
11506 south state street
draper UT 84020
MDR Report Key9221691
Report Number1721194-2019-00124
Device Sequence Number19445602
Product Code GEI
UDI-Device Identifier10614559100868
UDI-Public10614559100868
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K965054
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number0039H
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/25/2019
Initial Report FDA Received Date10/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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