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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 2.75IN; E-Z CLEAN BLADE MODIFIED 2.75 INCH
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MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 2.75IN; E-Z CLEAN BLADE MODIFIED 2.75 INCH Back to Search Results
Catalog Number 0012AM
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Batch # unk.Date of event is 2019.Event day and event month were not provided.
 
Event Description
It was reported by the distributor during an unknown procedure that when changing the cautery tip, the blue plastic piece became dislodged and free.It is unknown if there were any adverse consequences to the patient.
 
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Brand Name
E-Z CLEAN BLADE MOD 2.75IN
Type of Device
E-Z CLEAN BLADE MODIFIED 2.75 INCH
Manufacturer (Section D)
MEGADYNE MEDICAL PRODUCTS, INC.
11506 south state street
draper UT 84020
Manufacturer (Section G)
MEGADYNE MEDICAL PRODUCTS, INC.
Manufacturer Contact
kara ditty-bovard
11506 south state street
draper, UT 84020
6107428552
MDR Report Key9433889
MDR Text Key190808879
Report Number1721194-2019-00138
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10614559100103
UDI-Public10614559100103
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K081791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other
Type of Report Initial
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0012AM
Device Lot Number192483
Was Device Available for Evaluation? No
Date Manufacturer Received11/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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