MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-04-22 for DIALYSIS UNKNOWN manufactured by Covidien Mfg Solutions S.a..
[142735614]
(b)(4) title bilateral central vein stenosis: options for dialysis access and renal replacement therapy when all upper extremity access possibilities have been lost source j vasc access, volume 15, 2014(466-473) article number: 6 date of publication: 2 april 2014. If information is provided in the future, a supplemental report will be issued. [pe# (b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[142735615]
According to literature source of study performed between january 2009 and december 2012, on 146 patients with end-stage renal disease (esrd) to compare patency rates of different access and renal replacement treatment (rrt) modalities in patients with bilateral central vein stenosis/occlusion. One hundred forty-six vascular access modalities were attempted in 62 patients, of which 8 had received pd (peritoneal dialysis) catheter inserted into the peritoneum. It was stated in the study that on the 8 pd group 2 had culture-proven bacteraemia. No patients died as a result of loss of access. There was no reported patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00101 |
| MDR Report Key | 8537940 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date Mfgr Received | 2019-04-11 |
| Date Added to Maude | 2019-04-22 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALYSIS UNKNOWN |
| Generic Name | CATHETER, PERITONEAL, LONG-TERM INDWELLING |
| Product Code | FJS |
| Date Received | 2019-04-22 |
| Model Number | DIALYSIS UNKNOWN |
| Catalog Number | DIALYSIS UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-22 |