MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-11-21 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[128191505]
(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 used in this procedure? Citation: int j infertility fetal med 2013; 4 (1): 1-5. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128191506]
It was reported via journal article: title: "can we reduce fetal loss with second trimester miscarriages and very preterm births due to cervical incompetence in women with repeated failed vaginal cerclages and/or 'inaccesible' cervices? " citation: int j infertility fetal med 2013; 4 (1): 1-5. The objectives of the study was to assess the reduction in fetal loss following transabdominal cervicoisthmic cerclage done for repeated failed vaginal cerclages and/or inaccessible cervices. An observational study of 113 pregnancies in 90 women (age range: 26 to 30 years old) after transabdominal cervicoisthmic cerclage from january 1999 to december 2010 at fernandez hospital, hyderabad, andrha pradesh, india. During the procedure, a mersilene 5 mm tape (ethicon) with a swaged needle was used. The anterior leaf of broad ligament was pierced with the blunt needle and the tape was gently pulled through the paracervical space from anterior to posterior. The procedure was repeated on the other side. The tape was pulled tight around the cervix, and the ascending branches of the uterine arteries were palpated to confirm the presence of pulsations. Reported complications included rupture of membranes in the immediate post-operative period (n-1) which required removal of the mersilene tape through colpotomy and miscarriage on the day of surgery (n-1). It was reported that both events were considered to be procedure-related fetal losses in this series. Other reported complication included premature rupture of membranes (n-2) which required removal of the mersilene tape by colpotomy. The authors concluded that the transabdominal cervicoisthmic cerclage offers a high rate of fetal salvage in patients with extremely poor obstetric histories as a result of cervical incompetence, where vaginal cerclage is not possible or has repeatedly failed. The risk of procedure-related complications can be minimal in skilled hands. It is a specialized procedure for selected patients in whom it improves the perinatal outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77292 |
| MDR Report Key | 8095967 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-06 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2018-11-21 |
| 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 | 2018-11-21 |
| 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 | 2018-11-21 |