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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN PNCL RKR HLSTR BNS; E-Z CLEAN PENCIL ROCKER HOLSTER BNS
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MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN PNCL RKR HLSTR BNS; E-Z CLEAN PENCIL ROCKER HOLSTER BNS Back to Search Results
Catalog Number 0030HBN
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 neurosurgeon reported seeing "green flakes" under microscope.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.
 
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Brand Name
E-Z CLEAN PNCL RKR HLSTR BNS
Common Device Name
E-Z CLEAN PENCIL ROCKER HOLSTER BNS
Manufacturer (Section D)
MEGADYNE MEDICAL PRODUCTS, INC.
11506 south state street
draper UT 84020
MDR Report Key7966614
Report Number1721194-2018-00042
Device Sequence Number221731
Product Code GEI
UDI-Device Identifier10614559101322
UDI-Public10614559101322
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K965054
Number of Events Summarized1
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 Number0030HBN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/17/2018
Initial Report FDA Received Date10/15/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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