MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-12 for MEDIVATOR DSD EDGE G14SD manufactured by Medivators Inc..
[136527809]
Exophiala culture result from bal collected during bronchoscopy procedure. Patient symptoms not consistent with infection. Two other outpatient patients had bronchoscopies on (b)(6) 2019 and bal cultures came back on (b)(6) 2019 positive for exophiala.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083990 |
| MDR Report Key | 8336607 |
| Date Received | 2019-02-12 |
| Date of Report | 2019-02-08 |
| Date of Event | 2018-12-19 |
| Date Added to Maude | 2019-02-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDIVATOR DSD EDGE |
| Generic Name | BASIN FOR ENDOSCOPE REPROCESSING |
| Product Code | PHT |
| Date Received | 2019-02-12 |
| Returned To Mfg | 2019-02-08 |
| Model Number | G14SD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-12 |