MERSILENE TAPE UNKNOWN PRODUCT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-11-21 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..

Event Text Entries

[128191505] (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. Were the cases 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 used in this procedure? Citation: int j infertility fetal med 2013; 4 (1): 1-5. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[128191506] It was reported via journal article: title: "can we reduce fetal loss with second trimester miscarriages and very preterm births due to cervical incompetence in women with repeated failed vaginal cerclages and/or 'inaccesible' cervices? " citation: int j infertility fetal med 2013; 4 (1): 1-5. The objectives of the study was to assess the reduction in fetal loss following transabdominal cervicoisthmic cerclage done for repeated failed vaginal cerclages and/or inaccessible cervices. An observational study of 113 pregnancies in 90 women (age range: 26 to 30 years old) after transabdominal cervicoisthmic cerclage from january 1999 to december 2010 at fernandez hospital, hyderabad, andrha pradesh, india. During the procedure, a mersilene 5 mm tape (ethicon) with a swaged needle was used. The anterior leaf of broad ligament was pierced with the blunt needle and the tape was gently pulled through the paracervical space from anterior to posterior. The procedure was repeated on the other side. The tape was pulled tight around the cervix, and the ascending branches of the uterine arteries were palpated to confirm the presence of pulsations. Reported complications included rupture of membranes in the immediate post-operative period (n-1) which required removal of the mersilene tape through colpotomy and miscarriage on the day of surgery (n-1). It was reported that both events were considered to be procedure-related fetal losses in this series. Other reported complication included premature rupture of membranes (n-2) which required removal of the mersilene tape by colpotomy. The authors concluded that the transabdominal cervicoisthmic cerclage offers a high rate of fetal salvage in patients with extremely poor obstetric histories as a result of cervical incompetence, where vaginal cerclage is not possible or has repeatedly failed. The risk of procedure-related complications can be minimal in skilled hands. It is a specialized procedure for selected patients in whom it improves the perinatal outcome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2018-77292
MDR Report Key8095967
Report SourceFOREIGN,LITERATURE
Date Received2018-11-21
Date of Report2018-11-06
Date Mfgr Received2018-11-06
Date Added to Maude2018-11-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDARLENE KYLE
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 088760151
Manufacturer CountryUS
Manufacturer Postal088760151
Manufacturer Phone9082182792
Manufacturer G1ETHICON INC.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMERSILENE TAPE UNKNOWN PRODUCT
Generic NameINSTRUMENT, SURGICAL, DISPOSABLE
Product CodeKDC
Date Received2018-11-21
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-11-21

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