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 Hemorrhage/Bleeding (1888); Injury (2348)

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: 2017: the authors.Bjog an international journal of obstetrics and gynaecology (b)(4).

Event Description

It was reported via journal article: "title: cervical cerclage using the shirodkar technique: safe and effective as evidenced by a historical cohort covering 337 consecutive procedures" authors: bonney, e.; walker, j.And simpson, n.Citation: 2017: the authors.Bjog an international journal of obstetrics and gynaecology the aim of this study present findings from a single site cohort evaluating the performance of this technique in a tertiary level obstetric unit.Between february 2005 and march 2016, all women who underwent shirodkar cerclage were included in this study.Elective cerclage (n = 230) was performed prior to 16 weeks of gestation in women with a recurrent history of mid-trimester loss or early preterm birth.Ultrasound-indicated cerclage (n = 86) was carried out in asymptomatic women where transvaginal ultrasound examination revealed a short cervix (<20 mm) with or without collapse of the internal os.Rescue cerclage (n = 21) was undertaken where there were visible fetal membranes at the external cervical os or prolapsed within the upper vagina.Mersilene tape was used in each case.There were four complications following suture insertion: three bladder injuries at elective suture placement and one major hemorrhage (2l) at an ultrasound-indicated placement.All four pregnancies concluded successfully.In conclusion, our results demonstrate that shirodkar suture insertion using mersilene is a safe and effective technique for women in elective, ultrasound-indicated and rescue situations.These are reassuring data given recent concerns regarding colonization of braided sutures.

• 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: 8026147
• MDR Text Key: 125754012
• Report Number: 2210968-2018-76868
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• 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: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 10/31/2018
• 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