GUT CHROMIC SUTURE UNKNOWN PRODUCT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study report with the FDA on 2020-01-10 for GUT CHROMIC SUTURE UNKNOWN PRODUCT manufactured by Ethicon Inc..

Event Text Entries

[185897755] (b)(4). This report is related to data research, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events. If further details are received at a later date a supplemental medwatch will be sent. Additional device captured in mw 2210968-2020-00252.
Patient Sequence No: 1, Text Type: N, H10


[185897756] It was reported via clinical evaluation report from a related research activity database (drra) that patients underwent an unknown procedure on unknown date and suture was used. The reported complication experienced by the following with corresponding intervention: 6 patients had bleeding peri-operative complication after the procedure. 1 patient had sepsis peri-operative complication after the procedure. 2 patients had surgical site infection peri-operative complication after the procedure. 3 patients had wound disruption peri-operative complication after the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-00257
MDR Report Key9575313
Report SourceCOMPANY REPRESENTATIVE,STUDY
Date Received2020-01-10
Date of Report2019-12-14
Date Mfgr Received2019-12-14
Date Added to Maude2020-01-10
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.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGUT CHROMIC SUTURE UNKNOWN PRODUCT
Generic NameSUTURE, ABSORBABLE, NATURAL
Product CodeGAL
Date Received2020-01-10
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
101. Required No Informationntervention 2020-01-10

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