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 Sepsis (2067); Blood Loss (2597)

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.Citation: journal of perinatology (2009) 29, 276¿279; doi:10.1038/jp.2008.221 (b)(4).

Event Description

It was reported via journal article: "title : pregnancy outcome after placement of ¿rescue¿ shirodkar cerclage" author : g ventolini, tj genrich, j roth and r neiger citation: journal of perinatology (2009) 29, 276¿279; doi:10.1038/jp.2008.221 the purpose of this retrospective cohort study was to evaluate the pregnancy outcome of women who presented with advanced mid-trimester cervical dilation and bulging amniotic membranes who elected to undergo placement of shirodkar cervical cerclage compared with a small group of patients who opted for expectant management.Between 2jan2003 and 31dec2005, 56 female patients (average maternal age of 26.4±8.3 years) with late mid-trimester cervical dilatation who underwent placement of shirodkar cerclage.In the cerclage procedure, a 5mm mersilene tape was used.Following the placement of the cerclage, 8 patients experienced premature rupture of membranes and one of them occurred during the cerclage procedure.Another patient experienced excessive bleeding during placement of cerclage which required suturing of the cervix.Furthermore, one patient developed sepsis which required admission to intensive care unit and experienced fetal demise at (b)(6) gestation.The authors suggested that there was no correlation between the length of the cervix below the level of cerclage and gestational age at delivery.When pregnancies are complicated by late mid-trimester cervical dilation, placement of shirodkar cerclage in appropriately selected patients has the potential to be a beneficial therapeutic option.

• 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: 8119584
• MDR Text Key: 128879319
• Report Number: 2210968-2018-77423
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• 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: 11/12/2018
• 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