MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-05-07 for DIALYSIS UNKNOWN manufactured by Covidien Mfg Solutions S.a..
[144274316]
Title hemodialysis catheter design and catheter performance: a randomized controlled trial source am j kidney dis. , volume 64, 2014 (902-908) article number: 6 date of publication: 7 april 2014. If information is provided in the future, a supplemental report will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144274357]
According to the literature source of study performed between two hd (hemodialysis) catheter design, 135. 9 days for the first type of product and 136. 5 days for the second type of product. It was concluded that, primary assisted patency and incidence of infection and thrombosis were similar for both catheter types. The first catheter type required less thrombolysis and achieved higher blood flow rates than the second catheter type. These findings suggest that mechanical catheter design may improve catheter rheology but does not affect risks for thrombosis and infection and hence catheter survival. Catheter removal for infection occurred in 10 patients (6. 6%) with the catheter, resulting in a total infection rate of 0. 48/1,000 catheter-days. Removal for thrombosis that could not be resolved with thrombolysis occurred in 11 patients (7. 3%) with the same type of catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00119 |
| MDR Report Key | 8586461 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-07 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2019-05-07 |
| 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 | 2019-05-07 |
| 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. Other | 2019-05-07 |