MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-19 for POWERTRIALYSIS SLIMCATH, 15CM N/A 5863150 manufactured by Bard Reynosa S.a. De C.v. -9617592.
| Report Number | 3006260740-2020-00937 |
| MDR Report Key | 9857877 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-08-01 |
| Date Added to Maude | 2020-03-19 |
| 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 | KAYLA OLSEN |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225010 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERTRIALYSIS SLIMCATH, 15CM |
| Generic Name | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
| Product Code | NIE |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-05 |
| Model Number | N/A |
| Catalog Number | 5863150 |
| Lot Number | REDV2933 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Address | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL REYNOSA, TAMAULIPAS MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |