ETHILON*BLACK4-0 45CM (1)CP-25 15502T

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 2020-03-24 for ETHILON*BLACK4-0 45CM (1)CP-25 15502T manufactured by Ethicon Inc..

Event Text Entries

[188516528] (b)(4). Attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10


[188516529] It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used. During the procedure, the suture ruptured without applying extra tension. There were no adverse patient consequences reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-02318
MDR Report Key9874518
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-24
Date of Report2020-02-27
Date of Event2020-02-20
Date Mfgr Received2020-02-27
Device Manufacturer Date2019-01-23
Date Added to Maude2020-03-24
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 ContactKARA DITTY-BOVARD
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone6107428552
Manufacturer G1ETHICON INC.-BRAZIL
Manufacturer StreetRODOVIA PRESIDENTE DUTRA KM 154
Manufacturer CitySAO PAOLO 12240-908
Manufacturer CountryBR
Manufacturer Postal Code12240-908
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameETHILON*BLACK4-0 45CM (1)CP-25
Generic NameSUTURE, NONABSORBABLE, SYNTHETIC
Product CodeGAR
Date Received2020-03-24
Catalog Number15502T
Lot NumberAL6806
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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