BONE WAX 24X2.5G 1029754

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 2019-05-07 for BONE WAX 24X2.5G 1029754 manufactured by B.braun Surgical Sa.

Event Text Entries

[144322592] (b)(4). Reported device not marketed in the u. S. , however, similar devices or devices that share components, (b)(4) materials, process methods or other technological characteristics are registered within the u. S. K000021. If additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[144322593] The reporter indicated that there was no product inside the package. No other information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003639970-2019-00391
MDR Report Key8587346
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-05-07
Date of Report2019-05-23
Date Facility Aware2019-05-13
Date Mfgr Received2019-05-13
Date Added to Maude2019-05-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSAY CHROMIAK
Manufacturer Street3773 CORPORATE PARKWAY
Manufacturer CityCENTER VALLEY PA 18034
Manufacturer CountryUS
Manufacturer Postal18034
Manufacturer Phone8002581946
Manufacturer G1B/ BRAUN SURGICAL SA
Manufacturer Street121 CARRETERA DE TERRASSA
Manufacturer CityRUBI, 08191
Manufacturer CountrySP
Manufacturer Postal Code08191
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBONE WAX 24X2.5G
Generic NameHAEMOSTYPTICS, PROPHYLAXIS OF
Product CodeMTJ
Date Received2019-05-07
Returned To Mfg2019-04-25
Model Number1029754
Catalog Number1029754
Lot Number218504
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerB.BRAUN SURGICAL SA
Manufacturer Address121 CARRETERA DE TERRASSA RUBI, 08191 SP 08191


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-07

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