MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-11-20 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[128030335]
(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: obstet gynecol 2007;109:493? 4 - (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128030336]
It was reported via journal article: "title : vesicovaginal fistula formation after cervical cerclage mimicking premature rupture of membranes". Author : l. Lewis wall, md, dphil, fareesa khan, md, and stephanie adams, citation: obstet gynecol 2007;109:493? 4. This case report aimed to present a (b)(6)-year-old female patient who underwent placement of a mcdonald cervical cerclage using mersilene tape under spinal anesthesia for cervical insufficiency. Two weeks later patient began noticing intermittent episodes of vaginal wetness, but no indication of ruptured membrane and amniotic fluid volumes were normal at ultrasound examination. She was given oral indomethacin and subcutaneous terbutaline for recurrent preterm labor. A vesicovaginal fistula was diagnosed by filling the bladder with 300ml sterile water with 20ml methylene blue dye, and copious spillage of blue dye into the vagina occurred immediately after instillation. At cystoscopy, the mersilene tape was clearly visible in the posterior bladder just above the interureteric ridge. The cerclage was removed during caesarian delivery. After delivery, transurethral foley catheter was placed to allow spontaneous healing of the fistula, but it failed. She underwent transvaginal repair of vesicovaginal fistula 10 weeks after delivery. The fistula healed completely without further complications. Nine months after fistula repair, she had normal bladder function with no incontinence and no voiding dysfunction. The authors believed that the bladder was not penetrated directly during cerclage placement; rather, the mersilene tape was probably placed extremely close to the bladder and subsequently eroded through the urothelium over the course of the next few weeks. This process led to intermittent urine loss until the fistula became so large that the patient experienced continuous urinary leakage. The use of the shirodkar or a similar technique in which the bladder is mobilized off the cervix before suture placement may reduce the incidence of such injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77259 |
| MDR Report Key | 8091225 |
| Report Source | LITERATURE |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-12 |
| Date Mfgr Received | 2018-11-12 |
| Date Added to Maude | 2018-11-20 |
| 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 | 2018-11-20 |
| Catalog Number | UNK |
| Lot 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 | 2018-11-20 |