PROLENE*BLUE3-0 45CM(1)PS-1 PR P8663T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-27 for PROLENE*BLUE3-0 45CM(1)PS-1 PR P8663T manufactured by Ethicon Inc..

Event Text Entries

[188521293] (b)(4). A manufacturing record evaluation was performed for the finished device am2751 number, and no non-conformances were identified. 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. Additional information was requested and the following was obtained: do you confirm that a suture unit frayed and a suture broke during this lipoma resection procedure? Yes affirmative. How many frayed sutures during use in this single procedure? Initially 1. How many sutures were broken in this single procedure? In total there were 10 units how was the case completed? - another lot was used. Device return status - does not apply as the product was discarded. Note: event related to suture fray and suture broke reported via mw 2210968-2020-01492; additional suture breakage events reported via mw 2210968-2020-01491, 2210968-2020-02423, 2210968-2020-02424, 2210968-2020-02426, 2210968-2020-02427, 2210968-2020-02428, 2210968-2020-02429, 2210968-2020-02430.
Patient Sequence No: 1, Text Type: N, H10


[188521294] It was reported that the patient underwent resection of lipoma procedure on (b)(6) 2020 and suture was used. During the procedure, the suture was breaking at the time of lipoma resection. A device from another lot was used to complete the procedure. There were no adverse patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-02425
MDR Report Key9889332
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-27
Date of Report2020-03-02
Date of Event2020-01-27
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-06-14
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.-BRAZIL
Manufacturer StreetRODOVIA PRESIDENTE DUTRA KM 154
Manufacturer CitySAO PAOLO 12240
Manufacturer CountryBR
Manufacturer Postal Code12240
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROLENE*BLUE3-0 45CM(1)PS-1 PR
Generic NameSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Product CodeGAW
Date Received2020-03-27
Catalog NumberP8663T
Lot NumberAM2751
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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