MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-12-21 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[131143096]
(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: african journal of reproductive health september. 2012; 16(3): 180. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131143097]
It was reported via journal article: title: "pregnancy outcome after cerclage for cervical incompetence at the university of port harcourt teaching hospital, port harcourt", authors: john i. Ikimalo, kenneth e. Izuchukwu, nestor inimgba, citation: african journal of reproductive health september. 2012; 16(3): 180. The objective of this study was to document the feto-maternal outcome following cervical cerclage for cervical incompetence. The study reviewed a total of 44 cases of pregnant women (age range: 25 to 42 years old) who had cervical cerclage for cervical incompetence between january 1, 2004 to december 31, 2008, at the university of port harcourt teaching hospital. All the women had cervical cerclage done by the mcdonald? S method using mersilene tape (ethicon). Reported complications included iatrogenic rupture of membranes (n-1) and subsequently expelled products of conception, abnormal vaginal discharge (n-8), and preterm pre labor rupture of membranes (n-7). There is an improvement in pregnancy outcome after cervical cerclage for cervical incompetence hence, the authors recommend the insertion for true cases of cervical incompetence
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77968 |
| MDR Report Key | 8189161 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-04 |
| Date Mfgr Received | 2018-12-04 |
| Date Added to Maude | 2018-12-21 |
| 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 | 2018-12-21 |
| 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 | 2018-12-21 |