HISTOACRYL BLUE 0.5ML 1050044

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 2020-02-03 for HISTOACRYL BLUE 0.5ML 1050044 manufactured by B.braun Surgical Sa.

Event Text Entries

[178036899] Pma/510k: reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u. S. K111959. If additional information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[178036900] It was reported that the product is broken. The reporter indicated that the head nurse of the operating room complained that the glue was damaged during the operation. The event occurred before use on the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003639970-2020-00056
MDR Report Key9660626
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-03
Date of Report2020-02-03
Date Mfgr Received2020-01-16
Date Added to Maude2020-02-03
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. SILVIA ORUS
Manufacturer StreetCARRETERA DE TERRASSA, 121
Manufacturer CityRUBI, BARCELONA 08191
Manufacturer CountrySP
Manufacturer Postal08191
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 NameHISTOACRYL BLUE 0.5ML
Generic NameTISSUE ADHESIVES
Product CodeMPN
Date Received2020-02-03
Model Number1050044
Catalog Number1050044
Lot Number218403N2
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerB.BRAUN SURGICAL SA
Manufacturer Address121 CARRETERA DE TERRASSA RUBI, 08191 SP 08191


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-03

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