MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-12-13 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[130466158]
(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 obstetrics and gynaecology, february 2011; 31(2): 111? 117; doi: 10. 3109/01443615. 2010. 542512. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130466159]
It was reported via journal article "title: transabdominal cervical cerclage in triplet pregnancies and risk of extreme prematurity and neonatal loss". Author(s): j. E. Sumners, e. S. Moore, c. J. Ramsey & m. K. Eggleston citation: journal of obstetrics and gynaecology, february 2011; 31(2): 111? 117; doi: 10. 3109/01443615. 2010. 542512. The purpose of this retrospective cohort study was to compare gestational age and incidence of extreme pre-term delivery among triplet pregnancies who underwent a prophylactic transabdominal cerclage (tac) to those who underwent a prophylactic transvaginal cerclage (tvc) and those that did not have a cerclage. Between 1989 and 2009, 141 female patients who had triplet pregnancies were included and allocated into three groups: patients who had tvc procedures (n=60), patients who had tac procedures (n=31) and patients who did not have a cerclage (n=50). In patients who had prophylactic tvc, utilized a modified mcdonald technique with one or more large no. 2 ethibond sutures. In patients who had tac procedures, opposite ends of a 5mm mersilene band were drawn through and tied anteriorly. Two patients who received a prophylactic tvc had subsequent failure of the cerclage and underwent rescue tvc (n=1) and rescue tac (n=1). In prophylactic tac, one patient had erosion of cerclage tape through the lateral upper cervical wall occurring with labour at 33 weeks followed by an uneventful caesarian delivery and defect repair, with survival of all babies. Other complications included chorioamnionitis (n=2 tac, n=2 tvc) and premature rupture of membranes (n=7 tac, n=8 tvc). It was concluded that in triplet pregnancies, prophylactic placement of a tac appears to lower the incidence of delivery before 28 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77751 |
| MDR Report Key | 8162385 |
| Report Source | 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 | MERSILENE TAPE UNKNOWN PRODUCT |
| Generic Name | INSTRUMENT, SURGICAL, DISPOSABLE |
| Product Code | KDC |
| Date Received | 2018-12-13 |
| 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 | 2018-12-13 |