MERSILENE TAPE UNKNOWN PRODUCT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-12-19 for MERSILENE TAPE UNKNOWN PRODUCT manufactured by Ethicon Inc..

Event Text Entries

[130976603] (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: seminars in dialysis? Vol 22, no 2 (march? April) 2009 pp. 204? 208; doi: 10. 1111/j. 1525-139x. 2008. 00537. X. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[130976604] It was reported via journal article: "title: banding of hemodialysis access to treat hand ischemia or cardiac overload" authors: frank van hoek, marc scheltinga, martin luirink, huub pasmans, and charles beerenhout citation: seminars in dialysis? Vol 22, no 2 (march? April) 2009 pp. 204? 208; doi: 10. 1111/j. 1525-139x. 2008. 00537. X. This pilot study aimed to investigate the short-term and long-term efficacy of banding in patients with cardiac overload (co) or hemodialysis access induced distal ischemia (haidi). Between mar 2003 and jan 2008, a total of 17 patients with a direct hemodialysis access underwent banding because of co (n=8; n=3 male and n=5 female; aged of 51? 8 years) or hand ischemia (n=9; n=7 male and n=2 female; age of 59? 7 years). In the banding procedure, a 5-mm-wide flat mersilene band was loosely wrapped around the vein 1-3 cm from the anastomosis. The loose ends of the band were positioned into a specially designed pulling mechanism allowing narrowing of the venous outflow tract (?? Banding?? ) in a controlled manner. If banding was required for haidi, prolene 5. 0 suture was used to fix the metal clip which was used to secure the position of the band. Postoperatively, only two patients had recurrent co for which both underwent second banding. Complications including wound infections were not observed. Operative morbidity and mortality were absent. All patients successfully continued dialysis immediately after banding, and all accesses remained patent postoperatively (<3 months).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2018-77914
MDR Report Key8181793
Report SourceFOREIGN,LITERATURE
Date Received2018-12-19
Date of Report2018-12-04
Date Mfgr Received2018-12-04
Date Added to Maude2018-12-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDARLENE KYLE
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 088760151
Manufacturer CountryUS
Manufacturer Postal088760151
Manufacturer Phone9082182792
Manufacturer G1ETHICON INC.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMERSILENE TAPE UNKNOWN PRODUCT
Generic NameINSTRUMENT, SURGICAL, DISPOSABLE
Product CodeKDC
Date Received2018-12-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-12-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.