MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-11-30 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[128879319]
(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. Citation: journal of perinatology (2009) 29, 276? 279; doi:10. 1038/jp. 2008. 221 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128879320]
It was reported via journal article: "title : pregnancy outcome after placement of? Rescue? Shirodkar cerclage" author : g ventolini, tj genrich, j roth and r neiger citation: journal of perinatology (2009) 29, 276? 279; doi:10. 1038/jp. 2008. 221 the purpose of this retrospective cohort study was to evaluate the pregnancy outcome of women who presented with advanced mid-trimester cervical dilation and bulging amniotic membranes who elected to undergo placement of shirodkar cervical cerclage compared with a small group of patients who opted for expectant management. Between 2jan2003 and 31dec2005, 56 female patients (average maternal age of 26. 4? 8. 3 years) with late mid-trimester cervical dilatation who underwent placement of shirodkar cerclage. In the cerclage procedure, a 5mm mersilene tape was used. Following the placement of the cerclage, 8 patients experienced premature rupture of membranes and one of them occurred during the cerclage procedure. Another patient experienced excessive bleeding during placement of cerclage which required suturing of the cervix. Furthermore, one patient developed sepsis which required admission to intensive care unit and experienced fetal demise at (b)(6) gestation. The authors suggested that there was no correlation between the length of the cervix below the level of cerclage and gestational age at delivery. When pregnancies are complicated by late mid-trimester cervical dilation, placement of shirodkar cerclage in appropriately selected patients has the potential to be a beneficial therapeutic option.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77423 |
| MDR Report Key | 8119584 |
| Report Source | LITERATURE |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-12 |
| Date Mfgr Received | 2018-11-12 |
| Date Added to Maude | 2018-11-30 |
| 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 | 2018-11-30 |
| Catalog Number | UNK |
| Lot 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 | 2018-11-30 |