MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN BLADE MOD 6.5IN; E-Z CLEAN BLADE MODIFIED 6.5 INCH

Model Number	0014M
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unk.Investigation summary: one 0014m was received for evaluation.During visual inspection, a black fiber was found in the seal.The fiber exceeds specification.The complaint is confirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information was requested and the following was received: was the foreign matter inside the packaging blood or insect of product 0014m? => no.Further information is available.Was the stain found on the packaging of 0014am or was the stain found on the device of 0014am? =>stains were found on 0014am.
Event or Problem Description
It was reported that during an unknown procedure, a foreign matter was found inside 0014m and stains were on 0014am when the customer checked devices.Devices were not used for the patient.There were no adverse consequences to the patient.No further information is available.

• Brand Name: E-Z CLEAN BLADE MOD 6.5IN
• Common Device Name: E-Z CLEAN BLADE MODIFIED 6.5 INCH
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9780479
• Report Number: 1721194-2020-00025
• Device Sequence Number: 596266
• Product Code: GEI
• UDI-Device Identifier: 10614559100172
• UDI-Public: 10614559100172
• Combination Product (Y/N): N
• PMA/510(K) Number: K081791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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 Expiration Date: 08/31/2023
• Device Model Number: 0014M
• Device Catalogue Number: 0014M
• Device Lot Number: 185188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1