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 2018-12-28 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[131706399]
(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: j turk soc obstet gynecol. 2011; 8(3): 200- 4. Doi: 10. 5505/tjod. 2011. 25901 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131706400]
It was reported via journal article "title: sequential cervical cerclage in the same pregnancy: two multifetal pregnancy case reports" authors: eray caliskan, yigit cakiroglu, izzet yucesoy citation: j turk soc obstet gynecol. 2011; 8(3): 200- 4. Doi: 10. 5505/tjod. 2011. 25901 the authors presented a live healthy neonatal outcomes in two sequential cases, one twin and one triplet pregnancies, after emergency cerclage followed by second emergency cerclage due to cervical tear with a delayed delivery of 72 and 74 days respectively. Case 1, a (b)(6) female patient with and 21+2 weeks of gestation applied to our clinic with a complaint of vaginal fluid discharge. In the pelvic examination amniotic fluid collection was observed in the posterior fornix and the umbilical cord was hanging out from the cervix which was at a cervical dilatation of 2 centimeters. During the surgical procedure, the umbilical cord was pushed back into the cervix by binding with vicryl 0 sutures (ethicon). A mcdonald style proximal cervical cerclage was applied to the 2. 5 cm section of the cervix with a mersilene 5mm tape (ethicon) and a distal cerclage was applied to the distal portion with vicryl 1-0 sutures (ethicon). After the cerclage application the transvaginal cervical length was determined as 33 mm. In the last day of bed rest, a temporary oligohydramnios was detected and was recovered after abandoning the indomethasine treatment. In the routine pelvic examination on the 26th week of gestation, it was detected that the cervical cerclage suture had ruptured and became loose which required removal of the cerclage sutures and delivery of the first fetus. It was observed that the membranes belonging to the other fetus had preserved its completeness. Case 2, a (b)(6) female patient with lumbar and pelvic pain on the 18+5th week of her gestation of 3 fetuses. After the delivery was performed of the forerunner fetus of the triplets, the umbilical cord was pushed into the cervix both on the fetal and the placental sides by binding with vicryl 0 sutures (ethicon). A mcdonald style proximal cervical cerclage was applied to the 2. 5 cm section of the cervix with a mersilene 5mm tape (ethicon) and a distal cerclage was applied to the distal portion with vicryl 1-0 sutures (ethicon). After the cerclage application the transvaginal cervical length was determined as 26 mm. Reported complication included cervical cerclage suture had ruptured the cervix and the suture had opened which required second cerclage application. After a cerclage application, the success of the process and the durational extent of the postponement of the delivery depend on the effectiveness of the prevention of uterine contractions and the extent of the prevention of probable sub clinic infections. The usage of antibiotics and anti-inflammatory agents and the reduction of cytokine levels should be the real target during the passage of time for the postponement of the delivery of the remaining fetus. This approach also helps the remodeling of the cervix. The importance of cervical cerclage is the prevention of the inflammatory process by forming a physical barrier against the driving force pressure caused by the increase of prostaglandin and the dependent uterine contractions and the cervical deletion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-78077 |
| MDR Report Key | 8204202 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-12 |
| Date Mfgr Received | 2018-12-12 |
| Date Added to Maude | 2018-12-28 |
| 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 | 2018-12-28 |
| 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 | 2018-12-28 |