MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-12-19 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[130895619]
(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 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 used in this procedure? Citation: the journal of reproductive medicine volume 62, number 1-2, january-february 2017. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130895620]
It was reported via journal article: title: "a further application of detachable snare loops (endoloop) for repair of bladder injury," author(s): theodore tsaltas, m. D. , citation: the journal of reproductive medicine volume 62, number 1-2, january-february 2017. This study reported a case of a (b)(6) female patient who underwent shirodkar cerclage due to extensive cervical destruction from 2 prior procedures for dysplasia. She complained of dyspareunia and a vaginal mass (cervix scarred to the anterior vaginal wall down the vaginal barrel). Pressure on the cervix or uterine motion produced pain. She was advised to undergo laparoscopic hysterectomy. During the laparoscopic hysterectomy, extensive adhesion and inflammation were encountered anterior to the cervix managed by laparoscopic and vaginal dissection. After removal of the uterus, mersilene tape (used shirodkar cerclage) was noted during the closure of the vaginal cuff. Laparoscopic examination showed a 5mm tear in the bladder. The timing and location of the findings were compatible with the openings of an erosion created and occluded by the mersilene knot. Pathology confirmed extensive inflammation and erosion compatible with ulceration. Extensive inflammation precluded observational management. The bladder tear was managed in which the edges of the tear were closed using a laparoscopic allis forceps and a 0 pds endoloop. Irrigation showed the bladder intact. The ureters were patent and functioning. The injury site was watertight. This technique allows for rapid repair of even difficult bladder injuries of appropriate size under complex conditions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-77904 |
| MDR Report Key | 8180897 |
| Report Source | 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 | MERSILENE TAPE UNKNOWN PRODUCT |
| Generic Name | INSTRUMENT, SURGICAL, DISPOSABLE |
| Product Code | KDC |
| Date Received | 2018-12-19 |
| 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 |