MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-11-26 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[128311312]
(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: fertil steril 2011; 96: 895? 7; doi: 10. 1016/j. Fertnstert. 2011. 07. 009. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128311313]
It was reported via journal article: title: "successful tubal blastocyst transfer after laparoscopic cervical cerclage: cesarean delivery of a live very low-birth-weight infant and later hysterectomy for uterine rupture," authors: andrew murray, m. B. Ch. B. , f. R. A. N. Z. C. O. G. , and john hutton, ph. D. Citation: fertil steril 2011; 96: 895? 7; doi: 10. 1016/j. Fertnstert. 2011. 07. 009. This study aimed to report the management of a woman who presented with secondary infertility and amenorrhea after lletz procedure and a cone biopsy and who had cervical stenosis, a foreshortened cervix and hematometra. A (b)(6) female patient desired for further children after a cone biopsy for persistent abnormal cervical cytology underwent laparoscopic cervical cerclage using 5-mm mersilene tape. At (b)(6) gestation of the second ivf, she felt slight pelvic discomfort and was admitted with 3-cm herniation of the uterus posterior above where the tape was observed together with some free fluid in the pelvis. Three days after, repeat scan showed increased herniation posteriorly and subsequently underwent emergency caesarian delivery with a male infant weighing (b)(6). A 14-fr foley catheter with 10ml balloon was inserted through cervix and considerable traction was required for its removal 7 days later. Four months later, she had moderately severe pelvic cramps and the uterus was found distended with a 5-cm hematometra. She was treated with high-dose progestogen therapy with symptomatic relief but no reduction in hematometra. Two months later, she underwent percutaneous drainage of hematometra with a recurrence of pelvic cramps. A month later, hematometra recurred with severe pain requiring hospitalization and had a lower abdominal tenderness. Ultrasound scan showed reduction of hematometra and free-fluid in the pelvis. At laparotomy, a 1-cm uterine rupture just above the suture was noted and subtotal hysterectomy with removal of the tape was undertaken. Her recovery was protracted, but after 6 months, she was eventually pain free. This patient experienced after cervical cerclage the complication of herniation of the uterus, with premature cesarean delivery and later hematometra and uterine rupture necessitating hysterectomy. The site of the uterine herniation and the subsequent rupture was posterior just above the cerclage. The cerclage was associated with imminent uterine rupture during pregnancy, necessitating premature delivery of a very low-birth-weight infant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77330 |
| MDR Report Key | 8102721 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-07 |
| Date Mfgr Received | 2018-11-07 |
| Date Added to Maude | 2018-11-26 |
| 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 | 2018-11-26 |
| 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 | 2018-11-26 |