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 Urinary Tract Infection (2120); Post Operative Wound Infection (2446); Not Applicable (3189)

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: gynecol surg.2012; 9: 219¿222.Doi: 10.1007/s10397-011-0691-7.(b)(4).

Event Description

It was reported via journal article: title: "abdominal cerclage after failed transvaginal cervical cerclage." authors: anwar moria & nouf aljaji & louise miner & togas tulandi.Citation: gynecol surg.2012; 9: 219¿222.Doi: 10.1007/s10397-011-0691-7.The aim of this study was to evaluate the efficacy of abdominal cerclage by laparotomy and by laparoscopy among women who had failed transvaginal cerclage.The authors evaluated all women with cervical insufficiency that underwent abdominal cerclage between the years 2000 and 2010.Of a total of 20 patients, 12 patients (age: 34.4 ± 1.3; bmi: 24.9 ± 1.6) underwent abdominal cerclage by laparoscopy and 8 patients (age: 34.2 ± 0.8; bmi: 23.3 ± 2.4) underwent abdominal cerclage by laparotomy.During the procedure in both techniques, the authors started by dissecting the bladder peritoneum off the cervix and the authors used mersilene 5-mm tape (ethicon) for the cerclage.In the laparotomy technique, the suture was inserted through the avascular area of the paracervical tissue medial to the uterine vessels and at the level of the uterine isthmus.In the laparoscopic group, reported complications included severe oligohydramnios (n-1) which required laparoscopic removal of the cerclage.In the laparotomy group, reported complications included wound infection (n-1) and urinary tract infection (n-1).The authors concluded that abdominal cerclage in women who have failed a transvaginal cervical cerclage is associated with a high live birth rate and it could be performed by laparoscopy.

• 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: 8090712
• MDR Text Key: 127932189
• Report Number: 2210968-2018-77254
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• 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: 11/06/2018
• 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