BONE WAX UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-01-12 for BONE WAX UNK manufactured by Ethicon Inc..

Event Text Entries

[35681368] (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


[35681369] It was reported that the patient underwent an unknown procedure on unknown date and bone wax was used for control of bone bleeding and to seal air cells in the petrous bone to reduce chance of csf leak. The patient underwent re-operation to repair a csf leak. The surgeon opined the re-operation was required due to the sub-optimal adherence of the wax to the bone and its failure to stay in place allowing the csf leak to occur. At the time of re-operation the previously placed bone wax was dry, brittle, loosely attached to the bone. The patient is doing well currently.
Patient Sequence No: 1, Text Type: D, B5


[37189820] Corrected information: it was reported that this device is not malfunction reportable. Therefore, this medwatch report is not reportable.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2210968-2016-00652
MDR Report Key5360593
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-01-12
Date of Report2015-11-12
Date Mfgr Received2016-01-29
Date Added to Maude2016-01-12
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
Product CodeMTJ
Date Received2016-01-12
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-01-12

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