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 Problems Wound Dehiscence (1154); Unspecified Infection (1930); Inflammation (1932)

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 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 used in this procedure? citation: j.Obstet.Gynaecol.2014; 40(2): 381¿386.Doi: 10.1111/jog.12207.

Event Description

It was reported via journal article: "title: emergency cerclage versus expectant management for prolapsed fetal membranes: a retrospective, comparative study" authors: shigeru aoki, emi ohnuma, kentaro kurasawa, mika okuda, tsuneo takahashi, fumiki hirahara.Citation: j.Obstet.Gynaecol.2014; 40(2): 381¿386.Doi: 10.1111/jog.12207.The aim of the study was to compare the outcomes after emergency cerclage versus expectant management for prolapsed fetal membranes in women with cervical incompetency.The january 2000¿december 2012 hospital database was analyzed to identify women managed for prolapsed fetal membranes who did not have premature rupture of membranes, clinically discernible chorioamnionitis, or treatment-resistant uterine contractions from 15 to 26 weeks of gestation retrospectively.A total of 15 of the 35 women (age range: 27 to 42 years old) underwent emergency cervical cerclage (¿cerclage group¿), while the other 20 patients (age range: 30 to 42 years old) were managed expectantly (¿bedrest group¿).During the surgical procedure in the cerclage group, mersilene tape (ethicon) was used.In the cerclage group, reported complications included premature rupture of membrane (n-3), detachment of mersilene tape from the cervical mucosa (n-2), and chorioamnionitis (n-8).The present results suggest that in women with prolapsed fetal membranes who do not have prom, treatment-resistant uterine contractions or clinical chorioamnionitis, emergency cervical cerclage achieves greater prolongation of pregnancy than expectant management.

• 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: 8181276
• MDR Text Key: 131159363
• Report Number: 2210968-2018-77907
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• 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