MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-01-08 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[132394170]
(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. Author: peter e. Papa petros? And ulf i. Ulmsten. Citation: acta obstet gynecol scand 1990; 69 suppl 153: 53-59. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[132394171]
It was reported via journal article "title : the combined intravaginal sling and tuck operation. An ambulatory procedure for cure of stress and urge incontinence" author: peter e. Papa petros? And ulf i. Ulmsten citation: acta obstet gynecol scand 1990; 69 suppl 153: 53-59. The purpose of this study was to present the results of the combined intravaginal sling and tuck operation in patients with stress and urge incontinence. A total of 30 female patients with objectively demonstable stress incontinence underwent an ambulatory procedure of intravaginal sling and/or with combined tuck operation. In sling operation, the conical head was reversed, the 0. 5 ~ 4 5cm mersilene tape threaded through the eye of the needle, pulled down into the vagina, and the tunneler removed. The tape was painlessly removed as an office procedure 4 to 8 weeks later by cutting one and pulling on the other. Fifty percent of the patients failed to cure stress incontinence symptoms (new incidence of urgency or outflow obstruction) for which they underwent tuck operation. Between 2-6 weeks, 50% experienced suprapubic weeping. Further complications included mild postoperative vaginal bleeding (n=50%) which disappeared after tape removal; infected hematoma (n=1) and wound infection after tape removal. It is hypothesized that the postoperative bleeding that occurred in some patients was caused by the tunneler penetrating veins intermingled with the pubourethral ligament. The presence of the tape facilitates drainage even when an infected haematoma. Abscess formation on tape removal may have been due to a small infected haematoma caused by trauma to a granulation tissue blood vessel by pulling through a twisted tape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-78272 |
| MDR Report Key | 8227006 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-01-08 |
| Date of Report | 2018-12-20 |
| Date Mfgr Received | 2018-12-20 |
| Date Added to Maude | 2019-01-08 |
| 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 | 2019-01-08 |
| 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 | 2019-01-08 |