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 2018-11-27 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..

Event Text Entries

[128564646] (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. If further details are received at the 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 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: taiwanese journal of obstetrics & gynecology 56 (2017) 143-146; doi: http://dx. Doi. Org/10. 1016/j. Tjog. 2016. 05. 014. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[128564647] It was reported via journal article: title: "radical trachelectomy for early stage cervical cancer: a case series and literature review," authors: chin-jui wu, wen-chun chang, chi-hau chen, chi-an chen, su-cheng huang, bor-ching sheu. Citation: taiwanese journal of obstetrics & gynecology 56 (2017) 143-146; doi: http://dx. Doi. Org/10. 1016/j. Tjog. 2016. 05. 014. The aim of this article was to compare the oncologic and pregnancy outcomes of rt in the past decade in taiwan. Between 2002 and 2015, 10 patients with early stage cervical cancer underwent fertility-preserving radical trachelectomy (rt). Seven patients underwent vaginal rt (vrt) and 3 patients underwent abdominal rt (art). In vrt, the lower uterine segment of the cervix was sutured with mersilene tape. In art, the vaginal cuff was sutured to the lower uterine segment with 1-0 coated vicryl sutures. Cerclage was performed vaginally with the used of mersilene tape. "a" (b)(6) and (b)(6) female patients experienced unilateral hydronephrosis (n=2) for which one was transient and the other required regular ureter catheter replacement. A (b)(6) female patient developed urinary tract infection (n=1) which resolved with antibiotic treatment. She also developed cervical stenosis which required cervical dilatation twice. The authors believed that laparoscopic pelvic lymphadenectomy and vrt are safe and feasible treatment options for patients with early stage cervical cancer. These treatment procedures are associated with satisfactory oncological outcomes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2018-77357
MDR Report Key8107754
Report SourceFOREIGN,LITERATURE
Date Received2018-11-27
Date of Report2018-11-12
Date Mfgr Received2018-11-12
Date Added to Maude2018-11-27
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 NEEDLE, CERCLAGE, GYNECOLOGICAL
Product CodeKDC
Date Received2018-11-27
Catalog 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 2018-11-27

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