MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-12-19 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[131159363]
(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 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: j. Obstet. Gynaecol. 2014; 40(2): 381? 386. Doi: 10. 1111/jog. 12207.
Patient Sequence No: 1, Text Type: N, H10
[131159364]
It was reported via journal article: "title: emergency cerclage versus expectant management for prolapsed fetal membranes: a retrospective, comparative study" authors: shigeru aoki, emi ohnuma, kentaro kurasawa, mika okuda, tsuneo takahashi, fumiki hirahara. Citation: j. Obstet. Gynaecol. 2014; 40(2): 381? 386. Doi: 10. 1111/jog. 12207. The aim of the study was to compare the outcomes after emergency cerclage versus expectant management for prolapsed fetal membranes in women with cervical incompetency. The january 2000? December 2012 hospital database was analyzed to identify women managed for prolapsed fetal membranes who did not have premature rupture of membranes, clinically discernible chorioamnionitis, or treatment-resistant uterine contractions from 15 to 26 weeks of gestation retrospectively. A total of 15 of the 35 women (age range: 27 to 42 years old) underwent emergency cervical cerclage (? Cerclage group? ), while the other 20 patients (age range: 30 to 42 years old) were managed expectantly (? Bedrest group? ). During the surgical procedure in the cerclage group, mersilene tape (ethicon) was used. In the cerclage group, reported complications included premature rupture of membrane (n-3), detachment of mersilene tape from the cervical mucosa (n-2), and chorioamnionitis (n-8). The present results suggest that in women with prolapsed fetal membranes who do not have prom, treatment-resistant uterine contractions or clinical chorioamnionitis, emergency cervical cerclage achieves greater prolongation of pregnancy than expectant management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77907 |
| MDR Report Key | 8181276 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-03 |
| Date Mfgr Received | 2018-12-03 |
| Date Added to Maude | 2018-12-19 |
| 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 | 2018-12-19 |
| 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 | 2018-12-19 |