SFX SYM PDS+ UNI VIO 18IN 1 S/A CTXB SXPP1A300

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 2020-03-27 for SFX SYM PDS+ UNI VIO 18IN 1 S/A CTXB SXPP1A300 manufactured by Ethicon Inc..

Event Text Entries

[188247113] (b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10


[188247114] It was reported that the patient underwent an unknown chest surgery on (b)(6) 2020 and the barbed suture was used. During a surgery, the barbed suture was detached from the needle when pulling the suture. It was not a control release needle. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-02439
MDR Report Key9892129
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-02
Date of Event2020-03-03
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-27
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.-JUAREZ
Manufacturer StreetAVENIDA DE LAS TORRES 7125 COL SALVACAR
Manufacturer CityCIUDAD JUAREZ 32604
Manufacturer CountryMX
Manufacturer Postal Code32604
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSFX SYM PDS+ UNI VIO 18IN 1 S/A CTXB
Generic NameSUTURE, SURGICAL, ABSORBABLE
Product CodeNEW
Date Received2020-03-27
Model NumberSXPP1A300
Catalog NumberSXPP1A300
Lot NumberPH6360
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 2020-03-27

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