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..
[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
| Report Number | 2210968-2018-77357 |
| MDR Report Key | 8107754 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-12 |
| Date Mfgr Received | 2018-11-12 |
| Date Added to Maude | 2018-11-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERSILENE TAPE UNKNOWN PRODUCT |
| Generic Name | INSTRUMENT, SURGICAL, DISPOSABLE NEEDLE, CERCLAGE, GYNECOLOGICAL |
| Product Code | KDC |
| Date Received | 2018-11-27 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-27 |