MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-12-28 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[131701741]
(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: j. Perinat. Med. 28 (2000) 453 -457. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131701742]
It was reported via journal article "title: management of cervical cerclage at term: remove the suture in labor". Author(s): yaakov e. Abdelhak, rimma aronov, henry roque, and bruce k. Young citation: j. Perinat. Med. 28 (2000) 4532457. This retrospective analysis aimed to assess the risks and benefits to patients who carry to term after undergoing a shirodkar cerclage where the cerclage is not removed until the patient presents in labor. Over a 25-year span, from 01jan1974 to 01oct1998, 82 pregnant female patients who underwent shirodkar cerclage were qualified for the review. In the procedure, a 5-mm mersilene band was placed submucosally from posterior to anterior at the level of the internal os and tied anteriorly. The band and knot were buried by closing the mucosal incisions with a running 00 chromic suture. Complications included cervical laceration (n=3) which were repaired easily, and cervical dystocia (n=1) treated with pitocin and the baby was delivered via c-section. Allowing patients to proceed to labor with a shirodkar cerclage in place, does not increase the risks of cervical dystocia, cervical laceration, or uterine rupture above the reported incidence for these complications in patients in whom the cerclage is removed prophylactically.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-78084 |
| MDR Report Key | 8204604 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-12 |
| Date Mfgr Received | 2018-12-12 |
| Date Added to Maude | 2018-12-28 |
| 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 | 2018-12-28 |
| 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 | 2018-12-28 |