MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-12-28 for MERSILENE SUTURE 12"(30CM) 5-0 WHT RS21 manufactured by Ethicon Inc..
[131707362]
(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. Obstet. Gynaecol. Res. Vol. 36, no. 1: 209? 212, february 2010; doi:10. 1111/j. 1447-0756. 2009. 01097. X. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131707363]
It was reported via journal article "title: translocation of a cerclage band into the endocervical canal after preconception transabdominal cervico-isthmic cerclage" authors: moon-il park and jeong-kyu hoh. Citation: j. Obstet. Gynaecol. Res. Vol. 36, no. 1: 209? 212, february 2010; doi:10. 1111/j. 1447-0756. 2009. 01097. X. This study aimed to present a (b)(6) year-old female patient who had history of five spontaneous losses and failure of two mcdonald purse-string cerclages, who underwent transabdominal cervico-isthmic cerclage (tcc) for incompetent cervix as a management of recurrent second-trimester pregnancy loss and preterm delivery. In the procedure, the posterior peritoneum was punctured with an aneurysm needle, passing a single strip of #5 mersilene band (0. 5 cm wide, mersilene 5, rs21, ethicon, inc. Nj, usa) from the posterior to the anterior side. The procedure then was repeated on the contralateral side using the same piece of mersilene band. The mersilene band was adjusted to lie flat over the posterior peritoneum at the level of the origin of the uterosacral ligaments. Then it was tied anteriorly causing compression without undue constriction of the intervening tissue. Her seventh pregnancy was uncomplicated, but a migration of about one third of the mersilene band was found into the cervical canal. Cerclage band was not removed as patient wanted further pregnancy. Her further pregnancy reached 33 weeks? Gestation due to preterm labor without any signs of infection. Both tubal ligations were performed, and the cerclage band was removed at this time. Although it could have been a case of pure coincidence of preterm labor, we take a chance to speculate that the migration of the cerclage band into the endocervical canal might have been the reason for the preterm labor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-78079 |
| MDR Report Key | 8204371 |
| Report Source | LITERATURE |
| 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 SUTURE 12"(30CM) 5-0 WHT |
| Generic Name | CLASS I DEVICE - EXEMPT |
| Product Code | KDC |
| Date Received | 2018-12-28 |
| Catalog Number | RS21 |
| 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 |