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 2018-12-13 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[130317592]
(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: obstet gynecol. 2006; 107: 779? 84. -(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130317593]
It was reported via journal article "title: outcome after transabdominal cervicoisthmic cerclage" authors: frederik k. Lotgering, md, phd; ingrid p. M. Gaugler-senden, md; sabine f. Lotgering; henk c. S. Wallenburg, md, phd citation: obstet gynecol. 2006; 107: 779? 84. The objective of the study was to estimate benefits and risks of transabdominal cervicoisthmic cerclage in women with cervical insufficiency in whom transvaginal cerclage is considered surgically unfeasible. This was an observational cohort study with historical controls of 101 pregnancies after transabdominal cervicoisthmic cerclage in 101 women (age range: 22 to 41 years old) with a classic history of cervical insufficiency and severe cervical defects precluding transvaginal cerclage. During the surgical procedure, a 40-cm-long, 5-mm-wide mersilene band (ethicon) was grasped between the jaws of the clamp and gently pulled through the paracervical space from posterior to anterior. The procedure was repeated on the other side. The band was pulled tight around the cervix, and the ascending branches of the uterine arteries were palpated to confirm the presence of pulsations. The band was then tied snugly on the anterior side of the cervix and the cut ends of the band were fixed to the band with thin nonabsorbable sutures. The peritoneal bladder fold was closed over the band, and on the posterior side the band was left uncovered by peritoneum. Reported complications included operative hemorrhage (n-3) which required band tying and a few cases required stitches, exposure of membranes (n-1), and painful micturition (n-3). It was concluded that the results showed that the benefits of transabdominal cervicoisthmic cerclage outweigh its inherent disadvantages and risks in carefully selected patients with a diagnosis of cervical insufficiency in whom transvaginal approach is judged surgically unfeasible or hazardous. The authors recommended that women considered for transabdominal cervicoisthmic cerclage be referred for counseling and for the operation to a center with experience in performing the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77747 |
| MDR Report Key | 8162204 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2018-12-13 |
| Date of Report | 2018-11-26 |
| Date Mfgr Received | 2018-11-26 |
| Date Added to Maude | 2018-12-13 |
| 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 | 2018-12-13 |
| 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 | 2018-12-13 |