MAUDE Adverse Event Report: ETHICON INC. MERSILENE TAPE UNKNOWN PRODUCT; INSTRUMENT, SURGICAL, DISPOSABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

(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).

Event Description

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) year-old 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) year-old female patient with post-partum bleeding which required blood transfusion; case 4, a (b)(6) year-old female patient with preterm premature rupture of membranes; case 5, a (b)(6) year-old female patient with preterm premature rupture of membranes and chorioamnionitis; case 7, a (b)(6) year-old female patient with chorioamnionitis; case 8, a (b)(6) year-old female patient with preterm premature rupture of membranes; case 10, a (b)(6) year-old female patient with preterm premature rupture of membranes; and case 11, a (b)(6) year-old female patient with preterm premature rupture of membranes and chorioamnionitis.In the non-cerclage group, reported complications included case 12, a (b)(6) year-old female patient with preterm premature rupture of membranes; case 13, a (b)(6) year-old female patient with preterm premature rupture of membranes; case 15, a (b)(6) year-old female patient with chorioamnionitis; case 16, a (b)(6) year-old female patient with chorioamnionitis; case 17, a (b)(6) year-old female patient with preterm premature rupture of membranes; and case 20, a (b)(6) year-old 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.

• Brand Name: MERSILENE TAPE UNKNOWN PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8190408
• MDR Text Key: 131312306
• Report Number: 2210968-2018-77976
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR