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 Problems Laceration(s) (1946); Menstrual Irregularities (1959); Pain (1994); Pocket Erosion (2013)

Event Date 11/23/2020

Event Type  Injury  

Event Description

Title: comparison of laparoscopic abdominal cerclage and transvaginal cerclage for the treatment of cervical insufficiency: a retrospective study.This study aimed to investigate the pregnancy outcome after prophylactic cerclage performed either transvaginally or laparoscopically in patients with classical cervical insufficiency in a single center.A total of 154 women with cervical insufficiency who underwent prophylactic laparoscopic abdominal cervical cerclage (lac) and transvaginal cervical cerclage (tvc) were included in the study.There were 74 (48.1%) women in the lac group and 80 (51.9%) in the tvc group.The mean age of the lac group and tvc group was 30.7±3.8 years vs.31.6±4.4 years.The mean pre-pregnancy bmi of the lac group and tvc group was 24.9±4.4 kg/m2 vs.24.0±3.7 kg/m2.A 5mm mersilene tape (ethicon) was used in both cerclage procedures.Laparoscopic abdominal cervical cerclages require a cesarean section to terminate the pregnancy, and most transvaginal cervical cerclages can deliver transvaginal by removing the tape.Complications include mild chronic pelvic pain (n=4), hypomenorrhea (n=3), myometrial erosion (n=1), newly dysmenorrhea (n=1), and cervical laceration during delivery (n=4).In conclusion, we have found that the history-indicated prophylactic cerclage was an effective treatment for cervical insufficiency patients.The laparoscopic abdominal cervical cerclage preconception cerclage appeared to have a better pregnancy outcome conception to transvaginal cervical cerclage conception cerclage.Moreover, our limited experience suggested laparoscopic cervical cerclage before pregnancy is a recommended option for cervical insufficiency patients.

Manufacturer Narrative

(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 any of the ethicon products involved caused and/or contributed to the post-operative complications 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.Please confirm that the mersilene tape is not related to fetal deaths and pre-term deliveries.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: https://doi.Org/10.1007/s00404-020-05893-9.

Manufacturer Narrative

(b)(4).Date sent to the fda: 3/9/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The following information was requested but unavailable: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications 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.Please confirm that the mersilene tape is not related to fetal deaths and pre-term deliveries.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics?.

• 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: 13359466
• MDR Text Key: 289194291
• Report Number: 2210968-2022-00682
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2022
• 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