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 Inflammation (1932); 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: ultrasound obstet gynecol.2010; 36: 482¿485.Doi: 10.1002/uog.7675.(b)(4).

Event Description

It was reported via journal article: title: "clinical implication of intra-amniotic sludge on ultrasound in patients with cervical cerclage." authors: l.A.Gorski, w.H.Huang, b.K.Iriye and j.Hancock.Citation: ultrasound obstet gynecol.2010; 36: 482¿485.Doi: 10.1002/uog.7675.The aim of this study was to determine whether intra-amniotic (ia) sludge, a sonographic finding of hyperechoic matter in the amniotic fluid close to the internal cervical os, is associated with preterm delivery in patients with cervical cerclage.A retrospective cohort study of 177 patients who underwent mcdonald cerclage between january 1997 and december 2004 was conducted, of which, 60 patients (maternal age: 30.8 ± 5.4) had sonographic evidence of ia sludge (group 1) and 117 patients (maternal age: 29.6 ± 5.2) had absence of ia sludge (group 2).During the surgical procedure, cerclage was placed with a single mersilene 5-mm tape (ethicon) utilizing the mcdonald technique.In both groups, reported complications included vaginal bleeding (n-29; group 1: n-10 and group 2: n-19), preterm premature rupture of membranes (n-6; group 1: n-5 and group 2: n-1), and chorioamnionitis (n-3; group 1: n-2 and group 2: n-1).It was reported that ia sludge on ultrasound is not associated with an increased risk of preterm delivery in patients with cervical cerclage.The authors should exercise caution when treating patients with the sonographic finding of ia sludge and maintain the same level of vigilance as for any patient with an increased risk for preterm labor and delivery.

• 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: 8090573
• MDR Text Key: 127946335
• Report Number: 2210968-2018-77251
• 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: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/20/2018
• 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