MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 12INX3/16IN D/A CTX; CLASS I DEVICE - EXEMPT

Model Number RS22

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Does the surgeon believe that the mersilene tape caused and/or contributed to the preterm pre-labor rupture of membranes described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: best practice & research clinical obstetrics and gynaecology (2019);59:89-97.Https://doi.Org/10.1016/j.Bpobgyn.2019.06.001.

Event Description

Title: cervical cerclage in twin pregnancy.The aim of this study was to review the role of cervical cerclage in the prevention of preterm birth (ptb) in women with twin pregnancy.A total of 24 women [mean age of 31.5 ± 4.1 years (range 23-39 years)] who underwent a simplified laparoscopic cervical cerclage (lcc) were included in the study.Surgery was performed using a 5-mm mersilene tape (rs-22; ethicon, inc., somerville, nj, usa).Reported complications include second-trimester miscarriages (n=3), subsequent neonatal death due to extremely premature gestations (n=3), and preterm pre-labor rupture of membranes (n=1).In conclusion, lcc appears to be a safe, simple, and minimally invasive approach, which could potentially play an important role in women with established cervical incompetence and twin gestations who have had a failed tvc or a very short cervix that is not amenable to a tvc.The encouraging results presented in this review should be considered preliminary and confirmed in a larger cohort study.

• Brand Name: MERS TAPE WHT 12INX3/16IN D/A CTX
• Type of Device: CLASS I DEVICE - EXEMPT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13448102
• MDR Text Key: 285347619
• Report Number: 2210968-2022-00850
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049802
• UDI-Public: 10705031049802
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RS22
• Device Catalogue Number: RS22
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2022
• 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 Sex: Female