MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-12-14 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[130391771]
(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 (mersilene tape) used in this procedure? Citation: isrn obstetrics and gynecology. 2013; 5. Doi: http://dx. Doi. Org/10. 1155/2013/843158. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130391772]
It was reported via journal article: title: "outcome of late second trimester emergency cerclage in patients with advanced cervical dilatation with bulging amniotic membranes: a report of six cases managed at the douala general hospital, cameroon. " author: thomas obinchemti egbe, theophile nana njamen, gregory halle ekane, jacques kamgaing tsingaing, charlotte nguefack tchente, gerard beyiha, esther barla, and ernest nyemb. Citation: isrn obstetrics and gynecology. 2013; 5. Doi: http://dx. Doi. Org/10. 1155/2013/843158. The purpose of the study was to show the feasibility of emergency late second trimester cerclage with advanced cervical dilatation and bulging of amniotic membranes. This was a retrospective study of case files of patients who underwent emergency late second trimester cerclage with advanced cervical dilatation, some with bulging of fetal membranes between june 2003 and june 2010. A total of 6 patients (age range: 22 to 35 years old) underwent late second trimester cervical cerclage between 24 and 26 weeks of gestational age. During the surgical procedure, the bladder was mobilized cephalad with submucosal placement of a mersilene band (ethicon) anterior to posterior bilaterally at the level of the internal os, tying posteriorly and burying the anterior knot. Reported complications included preterm premature rupture of membranes (n-2) which required undo stitching chorioamnionitis (n-2) which required undo stitching. The authors recommended that salvage cervical cerclage should be considered in patients with advanced cervical dilatation and bulging membranes in the second trimester. Despite overall poor prognosis in such cases, successful outcomes may be obtained in selected cases especially when bulging of membranes has occurred no later than 24 hours and in the absence of maternal vaginal infection. The authors recommend facility based introduction of ultrasound scanning for the diagnosis of the short cervix and clinical risk factors for cervical insufficiency in order to fight against the poor morbidity/mortality related to this condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77774 |
| MDR Report Key | 8166044 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-12-14 |
| Date of Report | 2018-11-27 |
| Date Mfgr Received | 2018-11-27 |
| Date Added to Maude | 2018-12-14 |
| 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 |
| Product Code | KDC |
| Date Received | 2018-12-14 |
| 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 | 2018-12-14 |