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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 08/01/2019
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 that during a mass excision there was a flash as the surgical site from either the pencil or the tip.It is unknown how they finished the procedure.There were no adverse patient consequences.
 
Additional Manufacturer Narrative
(b)(4).Date sent: 10/4/2019.Additional information obtained:: no burn occurred, but there was a flash arc.
 
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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 Key8946953
Report Number1721194-2019-00117
Device Sequence Number2099348
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,Followup
Report Date (Section B) 08/02/2019
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? Yes
Initial Date Received by Manufacturer 08/02/2019
Supplement Date Received by Manufacturer09/25/2019
Initial Report FDA Received Date08/29/2019
Supplement Report FDA Received Date10/04/2019
Patient Sequence Number1
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