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

[131398785] (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. 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. Were the cases discussed in this article previously reported to ethicon? If yes, please provide a complaint reference number. Does the surgeon believe that ethicon products (mersilene tape or vicryl suture) involved caused and/or contributed to the post-operative complications described in the article? Does the surgeon believe there was any deficiency with the ethicon products (mersilene tape or vicryl suture) used in this procedure? Citation: j. Obstet. Gynaecol. Res. 2014; 40 (7): 1853? 1861. Doi: 10. 1111/jog. 12435. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[131398786] It was reported via journal article: title: "obstetric and neonatal outcomes of delayed interval delivery in cerclage and non-cerclage cases: an analysis of 20 multiple pregnancies. " authors: emek doger, yigit cakiroglu, yasin ceylan, emre kole, sebiha ozkan, eray caliskan. Citation: j. Obstet. Gynaecol. Res. 2014; 40 (7): 1853? 1861. Doi: 10. 1111/jog. 12435. The aim of the study was to compare maternal and fetal outcomes of pregnancies in which cerclage was placed following the loss of first fetus with those without cerclage placement in multiple pregnancies for delayed interval delivery. Records of pregnancies in which the first fetus was lost between 13? 26 weeks and delayed delivery experienced for retained fetus(es), were collected retrospectively. A total of 20 patients (age range: 20 to 40 years old) including 11 twins, seven triplets and two quadruplets were evaluated. Cases with cervical cerclage placed after the first delivery were evaluated as the cerclage group (11 patients) and the cases without cerclage placement were evaluated as the non-cerclage group (9 patients). In all cases who were suitable for the trial of delayed interval delivery and who had given informed consent, the placenta was left in situ after the first delivery. The umbilical cord of the first fetus was sutured with vicryl 0 (ethicon) and cut as high as possible at the cervical level. In the cerclage group, cerclage was performed by the placement of mersilene tape (ethicon) to the cervix in the directions, 12, 3, 6, and 9 o? Clock after gentle replacement of membrane which was prolapsed by wet sponges following irrigation of the vagina by povidone-iodine solution. In the cerclage group, reported complications included: case 1, a (b)(6) female patient with preterm premature rupture of membranes, chorioamnionitis, sepsis, and septic shock and was discharged in a healthy condition; case 3, a (b)(6) female patient with post-partum bleeding which required blood transfusion; case 4, a (b)(6) female patient with preterm premature rupture of membranes; case 5, a (b)(6) female patient with preterm premature rupture of membranes and chorioamnionitis; case 7, a (b)(6) female patient with chorioamnionitis; case 8, a (b)(6) female patient with preterm premature rupture of membranes; case 10, a (b)(6) female patient with preterm premature rupture of membranes; and case 11, a (b)(6) female patient with preterm premature rupture of membranes and chorioamnionitis. In the non-cerclage group, reported complications included case 12, a (b)(6) female patient with preterm premature rupture of membranes; case 13, a (b)(6) female patient with preterm premature rupture of membranes; case 15, a (b)(6) female patient with chorioamnionitis; case 16, a (b)(6) female patient with chorioamnionitis; case 17, a (b)(6) female patient with preterm premature rupture of membranes; and case 20, a (b)(6) female patient with chorioamnionitis. In conclusion, for the pregnancies remote from term, delay of the delivery of other fetuses that are retained after the birth of the first fetus may increase the survival chance of the newborn, and it is an alternative to the termination of pregnancy. A longer interval may be obtained by the implementation of cervical cerclage and this may contribute to the birthweight of the newborn.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2018-77974
MDR Report Key8190375
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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