MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-18 for MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT MERSSUTUNK manufactured by Ethicon Inc..
[188987587]
Product complaint # (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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: the journal of maternal-fetal & neonatal medicine, doi: 10. 1080/14767058. 2019. 1702960. 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. Does the surgeon believe that ethicon products (mersilene suture) 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 suture) used in this procedure? Were the cases discussed in this article previously reported to ethicon? Patient demographics (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188987588]
It was reported in a journal article with title: emergency cerclage following a standardized protocol offers an effective and safe therapeutic option for omen with high risk for prematurity? A retrospective monocentric cohort study on 130 pregnancies and 155 neonates. The aim of this case study is to demonstrate emergency cerclages (ecs) as a safe and effective therapeutic option to prevent severe prematurity or threatening miscarriage in midtrimester cervical insufficiency when treated by standardized protocol. This retrospective monocentric cohort study involving 130 pregnancies (105 single and 25 twin pregnancies) who underwent cerclage placements between july 2007 and june 2018. The majority of interventions were performed by mcdonald-type cerclages. Only patients with an intravaginal part of the cervix being less than 5mm were treated with a shirodka-type ec. A single purse-string suture with 5mm mersilene polyester bp-2 (40-mm length) (ethicon) was used. Reported complication included amnion-infection syndrome (n-12), septicemia (n-1), and early-onset neonatal sepsis related to cerclage (n-17) ec represent a safe and effective therapeutic option for preventing extreme premature birth in pregnancies with advanced midtrimester cervical dilation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02223 |
| MDR Report Key | 9851289 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-18 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC |
| Product Code | GAT |
| Date Received | 2020-03-18 |
| Catalog Number | MERSSUTUNK |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |