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 2019-01-22 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[133743283]
(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: am j obstet gynecol 2013; 208: 209. E1-9; doi: http://dx. Doi. Org/10. 1016/j. Ajog. 2012. 11. 039. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[133743284]
It was reported via journal article: title: "comparison of 2 stitches vs 1 stitch for transvaginal cervical cerclage for preterm birth prevention. " authors: maria a. Giraldo-isaza, md; grace p. Fried; sarah e. Hegarty, mphil; maria a. Suescum-diaz, md; arnold w. Cohen, md; vincenzo berghella, md. Citation: am j obstet gynecol 2013; 208: 209. E1-9; doi: http://dx. Doi. Org/10. 1016/j. Ajog. 2012. 11. 039. This retrospective cohort study aimed to compare outcome of 2 vs 1 stitch at the time of transvaginal cervical history-indicated or ultrasound-indicated cerclage placement for preterm birth prevention. Between jan1994 and jun2011, 444 pregnant female patients were included in the analysis and underwent history-indicated cerclage (n=237) and ultrasound-indicated cerclage (n=207). Of 237 who underwent history-indicated cerclage, 86 patients had 2 stitches (mean age sd of 29. 0? 6. 0 years) and 151 patients had 1 stitch (mean age of 30. 6? 5. 6 years). Of 207 who underwent ultrasound-indicated cerclage, 117 had 2 stitches (mean age sd of 27. 3? 6. 7 years) and 90 had 1 stitch (mean age sd of 28. 7? 5. 9 years). In patient who underwent history-indicated cerclage, mersilene 5 mm tape (n=9 in 2-stitch and n=108 in 1-stitch), polyester nonabsorbable braided suture including ethibond (n=70 in 2-stitch and n=26 in 1-stitch), prolene (n=10 in 2-stitch and n=1 in 1-stitch), and combination (n=6 in 2-stitch) were used. Similarly, in ultrasound-indicated cerclage mersilene 5 mm tape (n=2 in 2-stitch and n=61 in 1-stitch), polyester nonabsorbable braided suture including ethibond (n=110 in 2-stitch and n=24 in 1-stitch), prolene (n=3 in 2-stitch and n=5 in 1-stitch), and combination (n=2 in 2-stitch) were used. Complication on cerclage placement in history-indicated cerclage group included pregnancy loss <20 weeks (n=5 in 2-stitch and n=10 in 1-stitch), cervical laceration (n=1 in 2-stitch and n=1 in 1-stitch), repeat cerclage (n=4 in 2-stitch and n=4 in 1-stitch), and others such as excess bleeding, vesicovaginal fistula, stenosis and intraoperative rupture of membranes (n=1 in 2-stitch and n=1 in 1-stitch). At cerclage removal on the same group, complications included retained suture (n=1 in 2-stitch and n=8 in 1-stitch), cervical laceration (n=1 in 2-stitch and n=3 in 1-stitch), and others such as significant pain and bleeding (n=4 in 1-stitch). Furthermore, maternal and neonatal outcomes included chorioamnionitis (n=7 in 2-stitch and n=10 in 1-stitch). Complication on cerclage placement in ultrasound-indicated cerclage group included pregnancy loss <20 weeks (n=2 in 2-stitch and n=6 in 1-stitch), and repeat cerclage (n=8 in 2-stitch and n=2 in 1-stitch). At cerclage removal on the same group, complications included retained suture (n=9 in 2-stitch and n=5 in 1-stitch) and others such as significant pain and bleeding (n=2 in 2-stitch and n=2 in 1-stitch). Furthermore, maternal and neonatal outcomes included chorioamnionitis (n=15 in 2-stitch and n=12 in 1-stitch). The incidence and type of complications at cerclage placement and cerclage removal did not differ significantly. Cesarean section was significantly higher in the history-indicated 2 stitches group when compared with the 1 stitch group of women, and there was a trend for higher cesarean sections in the ultrasound-indicated 2 stitches group. Possible explanations for this finding could be scarring related to the use of a different type of suture or the additional stitch; however, this is unlikely based on the similarity of cesarean sections because arrest of labor. The findings of our study lead us to conclude that 1 stitch at the time of initial transvaginal cerclage placement is as effective as 2 stitches for preterm birth prevention less than 37 weeks? Gestation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-78545 |
| MDR Report Key | 8267403 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-09 |
| Date Mfgr Received | 2019-01-09 |
| Date Added to Maude | 2019-01-22 |
| 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 | 2019-01-22 |
| 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 | 2019-01-22 |