MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 30CMX5MM D/A CTX; CLASS I DEVICE - EXEMPT

Catalog Number RS22

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

Patient Problems Unspecified Infection (1930); Miscarriage (1962)

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) 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) used in this procedure? citation: j matern fetal neonatal med, 2016; 29(13): 2109¿2113; doi: 10.3109/14767058.2015.1076786 (b)(4).

Event Description

It was reported via journal article: "title: physical examination-indicated cerclage in singleton and twin pregnancies: maternal¿fetal outcomes" author(s): andrea bernabeu, maria goya, miquel martra, anna suy, laia pratcorona, carme merced, elisa llurba, manel casellas, elena carreras, and luis cabero citation: j matern fetal neonatal med, 2016; 29(13): 2109¿2113; doi: 10.3109/14767058.2015.1076786 this retrospective study aimed to study maternal and perinatal outcomes after physical examination-indicated cerclage in both singleton and twin pregnancies and evaluate the possible risk factors associated.Between jan2009 and dec2012, 60 female patients with singleton (n=53) or twin (n=3) pregnancies diagnosed with cervical incompetence and imminent risk of immature or preterm birth, underwent cerclage.The shirodkar cerclage technique was performed using mersilene (ethicon rs22, 5¿28 mm) under spinal anesthesia.Outcomes in singleton group included chorioamnionitis (n=7), premature rupture of membranes (prom) (n=16.7%) and miscarriage after cerclage (n=4).Outcome in twin pregnancy group included prom (n=1).Physical examination-indicated cerclage for cervical incompetence in women at risk for immature or preterm birth demonstrates good perinatal prognosis without increasing maternal morbidity in either singleton or twin pregnancies.The increase in gestation time in our study may also have been due to the fact that patients with subclinical chorioamnionitis were excluded by diagnostic amniocentesis.

• Brand Name: MERS TAPE WHT 30CMX5MM D/A CTX
• Type of Device: CLASS I DEVICE - EXEMPT
• 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: 8180339
• MDR Text Key: 130890912
• Report Number: 2210968-2018-77899
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049802
• UDI-Public: 10705031049802
• 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
• Device Catalogue Number: RS22
• 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