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..
[128642006]
(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
[128642007]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77380 |
| MDR Report Key | 8111998 |
| 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 | 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 | 2018-11-28 |