NOVOSYN VIOLET 1 (4) 90CM HR37S (M) C0068597

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 2020-03-31 for NOVOSYN VIOLET 1 (4) 90CM HR37S (M) C0068597 manufactured by B. Braun Surgical, S.a..

Event Text Entries

[186094600] If additional information becomes available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[186094601] It was reported that there was an issue with novosyn violet suture. The client reported that during handling there is a separation of the needle from the thread (needle detachment). Sutures were used for laparoscopic surgery and the procedure was prolonged due to this issue. No patient information is available due to privacy protection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003639970-2020-00177
MDR Report Key9907998
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-30
Date Mfgr Received2020-03-12
Date Added to Maude2020-03-31
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 CityRUB 08191
Manufacturer CountrySP
Manufacturer Postal08191
Manufacturer G1B. BRAUN SURGICAL, S.A.
Manufacturer StreetCARRETERA DE TERRASSA 121
Manufacturer CityRUB 08191
Manufacturer CountrySP
Manufacturer Postal Code08191
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOVOSYN VIOLET 1 (4) 90CM HR37S (M)
Generic NameSYNTHETIC ABSORBABLE BRAIDED S
Product CodeGAM
Date Received2020-03-31
Model NumberC0068597
Catalog NumberC0068597
Lot Number119462
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN SURGICAL, S.A.
Manufacturer AddressCARRETERA DE TERRASSA 121 RUB?, BARCELONA 08191 SP 08191


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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