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 Laceration(s) (1946); 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: j.Perinat.Med.28 (2000) 453 -457.(b)(4).

Event Description

It was reported via journal article "title: management of cervical cerclage at term: remove the suture in labor".Author(s): yaakov e.Abdelhak, rimma aronov, henry roque, and bruce k.Young citation: j.Perinat.Med.28 (2000) 4532457.This retrospective analysis aimed to assess the risks and benefits to patients who carry to term after undergoing a shirodkar cerclage where the cerclage is not removed until the patient presents in labor.Over a 25-year span, from 01jan1974 to 01oct1998, 82 pregnant female patients who underwent shirodkar cerclage were qualified for the review.In the procedure, a 5-mm mersilene band was placed submucosally from posterior to anterior at the level of the internal os and tied anteriorly.The band and knot were buried by closing the mucosal incisions with a running 00 chromic suture.Complications included cervical laceration (n=3) which were repaired easily, and cervical dystocia (n=1) treated with pitocin and the baby was delivered via c-section.Allowing patients to proceed to labor with a shirodkar cerclage in place, does not increase the risks of cervical dystocia, cervical laceration, or uterine rupture above the reported incidence for these complications in patients in whom the cerclage is removed prophylactically.

• 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: 8204604
• MDR Text Key: 131701741
• Report Number: 2210968-2018-78084
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• 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