MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-12-19 for MERS TAPE WHT 30CMX5MM D/A CTX RS22 manufactured by Ethicon Inc..
[130890912]
(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. Were the cases discussed in this article previously reported to ethicon? If yes, please provide a complaint reference number. Does the surgeon believe that ethicon products (mersilene tape) 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 (mersilene tape) used in this procedure? Citation: j matern fetal neonatal med, 2016; 29(13): 2109? 2113; doi: 10. 3109/14767058. 2015. 1076786 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130890913]
It was reported via journal article: "title: physical examination-indicated cerclage in singleton and twin pregnancies: maternal? Fetal outcomes" author(s): andrea bernabeu, maria goya, miquel martra, anna suy, laia pratcorona, carme merced, elisa llurba, manel casellas, elena carreras, and luis cabero citation: j matern fetal neonatal med, 2016; 29(13): 2109? 2113; doi: 10. 3109/14767058. 2015. 1076786 this retrospective study aimed to study maternal and perinatal outcomes after physical examination-indicated cerclage in both singleton and twin pregnancies and evaluate the possible risk factors associated. Between jan2009 and dec2012, 60 female patients with singleton (n=53) or twin (n=3) pregnancies diagnosed with cervical incompetence and imminent risk of immature or preterm birth, underwent cerclage. The shirodkar cerclage technique was performed using mersilene (ethicon rs22, 5? 28 mm) under spinal anesthesia. Outcomes in singleton group included chorioamnionitis (n=7), premature rupture of membranes (prom) (n=16. 7%) and miscarriage after cerclage (n=4). Outcome in twin pregnancy group included prom (n=1). Physical examination-indicated cerclage for cervical incompetence in women at risk for immature or preterm birth demonstrates good perinatal prognosis without increasing maternal morbidity in either singleton or twin pregnancies. The increase in gestation time in our study may also have been due to the fact that patients with subclinical chorioamnionitis were excluded by diagnostic amniocentesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77899 |
| MDR Report Key | 8180339 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-03 |
| Date Mfgr Received | 2018-12-03 |
| Date Added to Maude | 2018-12-19 |
| 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 | MERS TAPE WHT 30CMX5MM D/A CTX |
| Generic Name | CLASS I DEVICE - EXEMPT |
| Product Code | KDC |
| Date Received | 2018-12-19 |
| Catalog Number | RS22 |
| 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 | 2018-12-19 |