MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-11-28 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[128730164]
(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: gynecologic oncology 112 (2009) 506? 510; doi:10. 1016/j. Ygyno. 2008. 10. 029. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128730165]
It was reported via journal article: title: "abdominal radical trachelectomy: success and pitfalls in a general gynecologic oncology practice," author(s): alexander olawaiye, marcela del carmen, rosemary tambouret, annekathryn goodman, arlan fuller, linda r. Duska, citation: gynecologic oncology 112 (2009) 506? 510; doi:10. 1016/j. Ygyno. 2008. 10. 029. The purpose of this retrospective study was to report the successes and complications with a series of abdominal radical trachelectomies performed to preserve fertility in young women at the massachusetts general hospital (mgh). From 1999 to 2007, 10 female patients (average age of 31. 7 years [ranged 24. 8 to 38 years]) underwent radical abdominal "tracelectomy" with pelvic "lyphadenectomy". In the procedure, the re-anastomosis of the fundus to the vagina was performed using interrupted 2-0 pds sutures. The cerclage was accomplished using mersilene band which was tied around the neo-cervix and the bladder peritoneum and was sutured over the cerclage. The stitch was tied around the cervix with knot placed anteriorly. Postoperatively, complications included cervical stenosis (n=2) and dyspareunia (n=? ). The two patients with cervical stenosis both continued to have regular menses without hematometra (normal ultrasound) but a cytobrush could not be inserted into the new cervical canal. Long term complications included 2 cases of cerclage expulsion in a (b)(6) and (b)(6) female patients. The latter patient needed operating room visits for examination under anesthesia and pap smear. Radical abdominal trachelectomy can be successfully performed by any gynecologic oncologist who is trained in radical pelvic surgery. Patients must be aware of potential post-operative complications, including pre-term delivery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77377 |
| MDR Report Key | 8111406 |
| Report Source | LITERATURE |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-08 |
| Date Mfgr Received | 2018-11-08 |
| Date Added to Maude | 2018-11-28 |
| 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 | 2018-11-28 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-11-28 |