ABSORBABLE SURGICAL SUTURE NW2763

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 ABSORBABLE SURGICAL SUTURE NW2763 manufactured by Ethicon Inc..

Event Text Entries

[188258729] Product complaint (b)(4). Batch manufacturing records was reviewed for any process deviation but no deviation was observed. Attempts were made to obtain a device for evaluation. 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. What is the name of the procedure? What was used to complete the procedure? What is the current condition of the patient? What tissue was being approximated or sutured when it broke? Could you please confirm if we will receive the device? Product return status indicates availability unknown.
Patient Sequence No: 1, Text Type: N, H10


[188258730] It was reported that the patient underwent an unknown procedure on 3/1/2020 and the suture was used. During the procedure when surgeon pull suture for making knot, the suture break. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-02438
MDR Report Key9891982
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-02
Date of Event2020-03-01
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-04-01
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.-AURANGABAD INDIA
Manufacturer Street312379@B-15/1, M.I.D.C., 1 WALU
Manufacturer CityAURANGABAD
Manufacturer CountryIN
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABSORBABLE SURGICAL SUTURE
Generic NameSUTURE, ABSORBABLE, SYNTHETIC
Product CodeGAM
Date Received2020-03-27
Catalog NumberNW2763
Lot NumberT9001
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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