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..
[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
| Report Number | 2210968-2018-77914 |
| MDR Report Key | 8181793 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-04 |
| Date Mfgr Received | 2018-12-04 |
| 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 |