MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-11-20 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[127940829]
(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: j pak med assoc. 2012; 62 (6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[127940830]
It was reported via journal article: title: "morbidities of cervical cerclage: experience at a tertiary referral center. " authors: saba mubasshir, shama munim, ghulam zainab. Citation: j pak med assoc. 2012; 62 (6). The objective of the study was to determine the frequency of operative morbidities of cervical cerclage. A total of 70 women (age: 29. 4? 5. 2 years) undergoing cervical cerclage from april 2007 to december 2009 at the aga khan university hospital served as the study subjects. The surgical technique used was mcdonald's cervical suture using mersilene tape (ethicon) under general anesthesia. Reported complications included premature rupture of membranes (n-7) which were managed conservatively, fever (n-3) which was managed conservatively, pre-term labor (n-14) which were managed conservatively by giving progesterone suppositories by vaginal/rectal route, and vaginal bleeding (n-6) which were managed conservatively with bed rest and vaginal progesterone 400 mg daily. The results indicated that the risk of morbidities like ruptured membranes and chorioamnionitis remained small, but the risk of pre-term delivery was high. Sample size was a limitation in the study and larger study is required for subgroup analysis and for external validity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77253 |
| MDR Report Key | 8090651 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-06 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2018-11-20 |
| 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 | 2018-11-20 |
| Catalog Number | UNK |
| Lot 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 | 2018-11-20 |