BONE WAX UNK W31G

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 2015-12-03 for BONE WAX UNK W31G manufactured by Ethicon Inc..

Event Text Entries

[32615135] (b)(4). Date sent to the fda: 12/03/2015. (b)(4). Conclusion: the representative sample was received for evaluation. Visual and functional examinations revealed no defects and the ball of wax was spread on the folder without problems. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Patient Sequence No: 1, Text Type: N, H10


[32615136] It was reported that the patient underwent a craniotomy procedure on unknown date and bone wax was used. It was also reported that the use of bone wax resulted in post- operative brain bleeds requiring additional surgery. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


[35644815] It was reported that the patient underwent a craniotomy procedure on unknown date and bone wax was used. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[37193043] Corrected narrative: it was reported that the patient underwent craniotomy on an unknown date and bone wax was used. It was reported by the facility that the bone wax consistency was more brittle, seemed dry and was less sticky to the bone. There were no adverse patient consequences reported. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2210968-2015-19510
MDR Report Key5264438
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2015-12-03
Date of Report2015-11-13
Date Mfgr Received2016-01-29
Device Manufacturer Date2015-05-30
Date Added to Maude2015-12-03
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 NameWAX, BONE
Product CodeMTJ
Date Received2015-12-03
Returned To Mfg2015-12-02
Model NumberUNK
Catalog NumberW31G
Lot NumberAA3567
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2015-12-03

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