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 Hematoma (1884); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); 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: american journal of obstetrics and gynecology (2005) 192, 1989¿94; doi:10.1016/j.Ajog.2005.02.127.(b)(4).

Event Description

It was reported via journal article: title: "transvaginal placement of cervicoisthmic cerclage: report on pregnancy outcome." author(s): michael katz, md, carol abrahams, ms.Citation: american journal of obstetrics and gynecology (2005) 192, 1989¿94; doi:10.1016/j.Ajog.2005.02.127.This retrospective analysis was conducted to describe the pregnancy outcome for a large number of patients who had a transvaginal cervicoisthmic cerclage.Over a 10-year period, from 1992 to 2002, 53 pregnant women underwent surgery for transvaginal placement of a cerclage at the level of the cervicoisthmic junction between 12 and 17 weeks of gestation.In the procedure, a 5-mm mersilene tape was threaded very superficially, flat, through the tissue at anterior surface of the cervicoisthmic junction.One patient had her suture removed because of dyspareunia and vaginal discharge.Procedure-related complication included intrapartum cervical tear due to incomplete removal before labor (n=1); hematoma (<50ml) between bladder and cervix (n=1) that needed to be evacuated; and transient urinary retention with pelvic pain (n=2).Other postoperative complications included admission for removal of postcerclage hematoma (n=1); lower abdominal pain (n=1); and chorioamnionitis (n=2).The placement of transvaginal cervicoisthmic cerclage was associated with favorable pregnancy outcome and may be considered as a suitable safe alternative to the transabdominal cerclage.

• 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: 8028430
• MDR Text Key: 125794057
• Report Number: 2210968-2018-76871
• 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: Physician
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2018
• 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