MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2018-11-27 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[128562339]
(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 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: the journal of maternal-fetal and neonatal medicine, 2012; 25(9): 1779? 1782; doi: 10. 3109/14767058. 2012. 663830 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128562340]
It was reported via journal article "title : effect of cerclage on labor course and obstetric outcome: a case-control study" author : jae eun shin, jong chul shin, sa jin kim & young lee citation: the journal of maternal-fetal and neonatal medicine, 2012; 25(9): 1779? 1782; doi: 10. 3109/14767058. 2012. 663830 the objective of this retrospective case-control study was to evaluate the effects of cerclage on labor course and obstetric complications, and to determine whether there is an association between cerclage and cesarean delivery rate. From 1994 to 2009, a total of 127 female patients (mean? Sd age of 31. 0? 4. 0 years) underwent cervical cerclage which were matched in control group comprising 254 female patients (mean? Sd age of 32. 8? 3. 8 years). All cerclage were performed using mcdonald technique and the suture was made using mersilene tape. Dysfunctional labor and perinatal outcomes included prolonged latent phase, arrest of dilatation, cervical laceration (n=12) requiring surgical repair, and postpartum hemorrhage (n=3) for which one patient recovered after conservative treatment and two patients had to undergo emergency hysterectomy for bleeding due to uterine rupture and deep cervical lacerations that extended to the lower uterine segment and could not be sutured sufficiently by the vaginal approach. In this study, cerclage was associated with an increased incidence of a prolonged latent phase, but not with an increased total duration of labor or an increased rate of cesarean deliveries. Cerclage may affect cervical effacement, but once softening is achieved, labor appears to progress in the normal way. Cerclage may affect the processes involved in the degradation of collagen, leading to a prolonged latent phase by cervical scarring. A possible reason for cervical laceration in cerclage was that the foreign body reaction around the cervical stitch and the resulting scar tissue make the cervix more susceptible to injury during delivery. Another possible explanation is that the insufficient cervix was intrinsically more prone to injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77351 |
| MDR Report Key | 8107389 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-09 |
| Date Mfgr Received | 2018-11-09 |
| Date Added to Maude | 2018-11-27 |
| 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 NEEDLE, CERCLAGE, GYNECOLOGICAL |
| Product Code | KDC |
| Date Received | 2018-11-27 |
| 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 | 2018-11-27 |