MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-12-31 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[131715436]
(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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Was the case discussed in this article previously reported to ethicon? If yes, please provide a complaint reference number. Does the surgeon believe that ethicon product involved caused and/or contributed to the post-operative complications described in the article? Does the surgeon believe there was any deficiency with the ethicon products used in this procedure? Citation: j reprod med 2017; 62:675-677. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131715437]
It was reported via journal article: "title: bladder erosion related to shirodkar cerclage placement". Author(s): john s. Joyce, md, christopher p. Chung, md, paul m. Yandell, md. Citation: j reprod med 2017; 62:675-677. This case report aimed to present a (b)(6) year-old postmenopausal woman who had shirodkar cerclage placed in 1984 using mersilene tape, presented for recurrent hematuria and urinary tract infections with urinary frequency, urgency, nocturia, dyspareunia and persistent vaginal discharge. Upon examination, the cerclage was visualized at the level of the internal os and adjacent to the bladder. An office cystoscopy revealed marked inflammatory changes involving the left hemitrigone. A knot of mersilene tape and braided suture was visible to the suspected location of the left ureteral orifice. She underwent operative cystoscopy in which the eroded mersilene tape was removed with assistance of carter-thomason closesure system. At 6 weeks follow-up, she had complete resolution of her preoperative symptoms and she remained asymptomatic 18 months postoperatively. Shirodkar cerclage is still susceptible to delayed erosion into the bladder despite its paracervical dissection, regardless of prior surgery on the cervix.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-78082 |
| MDR Report Key | 8206154 |
| Report Source | LITERATURE |
| Date Received | 2018-12-31 |
| Date of Report | 2018-12-10 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2018-12-31 |
| 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 | 2018-12-31 |
| 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 | 2018-12-31 |