MERSILENE TAPE UNKNOWN PRODUCT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-12-21 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..

Event Text Entries

[131143096] (b)(4). This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. Citation: african journal of reproductive health september. 2012; 16(3): 180. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[131143097] It was reported via journal article: title: "pregnancy outcome after cerclage for cervical incompetence at the university of port harcourt teaching hospital, port harcourt", authors: john i. Ikimalo, kenneth e. Izuchukwu, nestor inimgba, citation: african journal of reproductive health september. 2012; 16(3): 180. The objective of this study was to document the feto-maternal outcome following cervical cerclage for cervical incompetence. The study reviewed a total of 44 cases of pregnant women (age range: 25 to 42 years old) who had cervical cerclage for cervical incompetence between january 1, 2004 to december 31, 2008, at the university of port harcourt teaching hospital. All the women had cervical cerclage done by the mcdonald? S method using mersilene tape (ethicon). Reported complications included iatrogenic rupture of membranes (n-1) and subsequently expelled products of conception, abnormal vaginal discharge (n-8), and preterm pre labor rupture of membranes (n-7). There is an improvement in pregnancy outcome after cervical cerclage for cervical incompetence hence, the authors recommend the insertion for true cases of cervical incompetence
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2018-77968
MDR Report Key8189161
Report SourceFOREIGN,LITERATURE
Date Received2018-12-21
Date of Report2018-12-04
Date Mfgr Received2018-12-04
Date Added to Maude2018-12-21
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 ContactDARLENE KYLE
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 088760151
Manufacturer CountryUS
Manufacturer Postal088760151
Manufacturer Phone9082182792
Manufacturer G1ETHICON INC.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMERSILENE TAPE UNKNOWN PRODUCT
Generic NameINSTRUMENT, SURGICAL, DISPOSABLE
Product CodeKDC
Date Received2018-12-21
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 088760151 US 088760151


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-12-21

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