SILKAM BLACK 3/0 (2) 45CM HS21 C0762261

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 2020-03-18 for SILKAM BLACK 3/0 (2) 45CM HS21 C0762261 manufactured by B. Braun Surgical, S.a..

Event Text Entries

[183934972] If additional information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[183934973] It was reported that there was an issue with silkam suture. The client reported that the needle was detached from the thread repeatedly during a dental surgery. It increases consumption and risk for the patient. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003639970-2020-00170
MDR Report Key9847933
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-02-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2019-07-01
Date Added to Maude2020-03-18
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 S OR
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 NameSILKAM BLACK 3/0 (2) 45CM HS21
Generic NameOTHER SUTURE
Product CodeGAP
Date Received2020-03-18
Model NumberC0762261
Catalog NumberC0762261
Lot Number619271
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN SURGICAL, S.A.
Manufacturer AddressCARRETERA DE TERRASSA, 121 RUB?, 08191 SP 08191


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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