MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-12-13 for MERS TAPE WHT 30CMX5MM D/A CTX RS22 manufactured by Ethicon Inc..
[130326151]
(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 (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: j gynecol obstet hum reprod 46 (2017) 343? 347; doi: http://dx. Doi. Org/10. 1016/j. Jogoh. 2017. 02. 003.
Patient Sequence No: 1, Text Type: N, H10
[130326152]
It was reported via journal article "title: evaluation of a new technique of prophylactic cervical cerclage simplified from the shirodkar cerclage: a pilot study" author(s): s. Bartolo , c. Garabedian, p. Deruelle , v. Debarge, a. -s. Ducloy-bouthors, d. Subtil citation: j gynecol obstet hum reprod 46 (2017) 343? 347; doi: http://dx. Doi. Org/10. 1016/j. Jogoh. 2017. 02. 003. This retrospective and comparative single-center study aimed to compare the results of high cervical cerclage, according to a simplified shirodkar technique, with those of a classic mcdonald cerclage, in the case of women at high risk of prematurity in an exploratory study. From jan2006 and jan2013, 38 underwent cerclage and were divided into two groups: mcdonald group (n=24) and simplified shirodkar group (n=14). Both the treatment groups utilized mersutures. Cerclage in mcdonald technique was described by weaving a braid through the connection of the middle-third/upper-third of the cervix, by passing six or four cardinal points, and by tying the two strands at the front of the cervix using mersutures f1513, ethicon. Cerclage in simplified shirodkar technique, this was facilitated by the nature of the doubly crimped thick strip, which allows starting the strap at about a radius of 6 hours back and strongly tying the knot on a radius of 12 hours before using mersutures rs 22u, ethicon. Complication in simplified shirodkar group included preterm premature of membrane (pprom) >37weeks of gestation (n=2) of which one case occurred a day after cerclage. Complications in mcdonald group included antenatal signs of chorioamnionitis (n=3) and preterm premature rupture of membranes <37 weeks of gestation (n=4). No significant difference was observed in the rate of surgical complications or hospitalizations during the pregnancies. The study was able to demonstrate an advantage to using the simplified shirodkar technique? High cervical cerclage? Compared with use of the mcdonald technique? Classical cerclage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77746 |
| MDR Report Key | 8162128 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-12-13 |
| Date of Report | 2018-11-26 |
| Date Mfgr Received | 2018-11-26 |
| Date Added to Maude | 2018-12-13 |
| 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 | MERS TAPE WHT 30CMX5MM D/A CTX |
| Generic Name | CLASS I DEVICE - EXEMPT |
| Product Code | KDC |
| Date Received | 2018-12-13 |
| Catalog Number | RS22 |
| 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 | 2018-12-13 |