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 Abdominal Pain (1685); Blood Loss (2597)

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.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.Was the case discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (mersilene tape) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (mersilene tape) used in this procedure? citation: obstetric case reports, 849-850; web address: doi: 10.3109/01443615.2015.1013924.(b)(4).

Event Description

It was reported via journal article: title: "an extraordinary complication of emergency cervical cerclage in a 20 weeks¿ gestation: cervicoisthmic rupture," author(s): t.Aydin, b.Yucel, e.Cinar, h.Aksoy & u.Aksoy.Citation: obstetric case reports, 849-850; web address: doi: 10.3109/01443615.2015.1013924.This case report aimed to present (b)(6) female patient who underwent emergency cervical cerclage (ecc).Cervical cerclage was carried out by the mcdonald technique with single-stitch mersilene tape.At 20 weeks¿ gestation, she presented of severe abdominal pain, contractions and bleeding for 2 hours of which cervicoisthmic rupture (2-cm transverse rupture of posterior aspect of cervix, membranes bulging through the defect) occurred with temperature of 39°c, pulse rate of 112 bpm and blood pressure of 90/60.Broad spectrum of antibiotic therapy was started.Hysterotomy was also preferred to avoid further uncontrolled extension of the rupture.The foetus was delivered, and the cerclage suture was removed.The cervicoisthmic rupture was controlled both from intrauterine and vaginal sides.She made an uneventful recovery.A week later, the rupture began to close.After 1 month, the rupture was completely closed.The most important known complications are chorioamnionitis, early rupture of the membranes and primary foetal death.Ecc should be performed by experienced surgeons.It is important to keep in mind that cervicoisthmic rupture from the suture line can occur as a rare complication.

• 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: 8055401
• MDR Text Key: 126724508
• Report Number: 2210968-2018-77068
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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

• Date FDA Received: 11/09/2018
• 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: 10/24/2018
• 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: 32 YR