BONE WAX UNK W810T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-11-17 for BONE WAX UNK W810T manufactured by Ethicon Inc..

Event Text Entries

[31449552] (b)(4): to date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
Patient Sequence No: 1, Text Type: N, H10


[31449553] It was reported that the patient underwent an unknown procedure on unknown date and bone wax was used. Prior to use on the patient, sterile labeling was not found on primary packaging. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2015-18496
MDR Report Key5231021
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2015-11-17
Date of Report2015-11-03
Date of Event2015-09-15
Date Mfgr Received2015-11-02
Date Added to Maude2015-11-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactGUILLERMO VILLA
Manufacturer StreetROUTE 22 WEST PO BOX 151
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone9082180707
Manufacturer G1ETHICON INC.-BRAZIL
Manufacturer StreetRODOVIA PRESIDENTE DUTRA, KM 1 54
Manufacturer CitySAO PAOLO 12240-908
Manufacturer CountryBR
Manufacturer Postal Code12240-908
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameBONE WAX
Generic NameSTERILE NONABSORBABLE BONE WAX
Product CodeMTJ
Date Received2015-11-17
Model NumberUNK
Catalog NumberW810T
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151


Patients

Patient NumberTreatmentOutcomeDate
10 2015-11-17

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