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 Foreign Body Reaction (1868); Abnormal Vaginal Discharge (2123)

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: african journal of reproductive health september.2012; 16(3): 180.(b)(4).

Event Description

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.

• 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: 8189161
• MDR Text Key: 131143096
• Report Number: 2210968-2018-77968
• 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: 12/04/2018

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
• 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