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 Blood Loss (2597); 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.2013; 10 (1): s1¿s151.(b)(4).

Event Description

It was reported via journal article: title: "laparoscopic cervical cerclage in patient with recurrent pregnancy loss (clinical case)," authors: veresnyuk nataliya, pyrohova vira, vernikovskyy igor, malaschynska mariya.Citation: gynecol surg.2013; 10 (1): s1¿s151.Cervical incompetence is the cause of 18 to 37% of the second trimester pregnancy losses.Abdominal cervical cerclage is quite appropriate procedure for women who have the history of previous failure of vaginal cerclage.The authors described a case of the laparoscopic cervical cerclage in a (b)(6) woman with recurrent miscarriage and cervical incompetence.The authors performed a laparoscopic abdominal cervical cerclage using mersilene tape suture (ethicon) before the patient¿s pregnancy to treat cervical incompetence.Reported complications included premature rupture of membranes, insignificant vaginal bleeding, and partial slipping of tissues of uterine isthmus past the tape which required removal of the tape.The abdominal procedure in contrast to vaginal cerclage is more difficult to perform and is more dangerous due to its potential complications.The patients who have undergone laparoscopic cervical cerclage require a careful supervision and need to be delivered by caesarean section.

• 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: 8047976
• MDR Text Key: 126442129
• Report Number: 2210968-2018-77028
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: UP
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• 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: 10/26/2018
• 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
• Patient Age: 31 YR