MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-13 for LOFRIC ORIGO 44312 manufactured by Wellspect Healthcare, A Division Of Dentsply Ih Ab.
| Report Number | 3009632672-2020-00004 |
| MDR Report Key | 9828351 |
| Report Source | CONSUMER |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-22 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2020-01-06 |
| Date Added to Maude | 2020-03-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARIN FREDRIKSSON |
| Manufacturer Street | AMINOGATAN 1 P.O. BOX 14 |
| Manufacturer City | MOELNDAL, SE-43121 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-43121 |
| Manufacturer G1 | WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB |
| Manufacturer Street | AMINOGATAN 1 P.O. BOX 14 |
| Manufacturer City | MOELNDAL, SE-43121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-43121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOFRIC ORIGO |
| Generic Name | CATHETER STRAIGHT |
| Product Code | EZD |
| Date Received | 2020-03-13 |
| Model Number | 44312 |
| Catalog Number | 44312 |
| Lot Number | 447039 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB |
| Manufacturer Address | AMINOGATAN 1 P.O. BOX 14 MOELNDAL, SE-43121 SW SE-43121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-13 |