MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for X-FLOW DUFO 3WAY SIL AB63201002 AB6320 manufactured by Coloplast A/s.
| Report Number | 9610711-2020-00011 |
| MDR Report Key | 9903153 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH O'GARA |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | COLOPLAST A/S MANUFACTURING |
| Manufacturer Street | 9 AVENUE EDMOND ROSTAND |
| Manufacturer City | SARLAT-LA-CANEDA 24206 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 24206 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-FLOW DUFO 3WAY SIL |
| Generic Name | SILICONE CATHETER |
| Product Code | EZL |
| Date Received | 2020-03-31 |
| Model Number | AB63201002 |
| Catalog Number | AB6320 |
| Lot Number | 6929199 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |