MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-06-10 for HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TEST IMS-1373 manufactured by Crosstex Sps Medical.
| Report Number | 1319130-2019-00002 |
| MDR Report Key | 8683867 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-06-10 |
| Date of Report | 2019-06-10 |
| Date of Event | 2019-05-22 |
| Date Mfgr Received | 2019-05-22 |
| Device Manufacturer Date | 2018-07-12 |
| Date Added to Maude | 2019-06-10 |
| 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 | LAUREN JOHNSON |
| Manufacturer Street | 31 WATER STREET #1 |
| Manufacturer City | CUBA 14727 |
| Manufacturer Country | US |
| Manufacturer Postal | 14727 |
| Manufacturer G1 | CROSSTEX SPS MEDICAL |
| Manufacturer Street | 31 WATER STREET #1 |
| Manufacturer City | CUBA, NY 14727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14727 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TEST |
| Generic Name | BIOLOGICAL INDICATOR |
| Product Code | FRC |
| Date Received | 2019-06-10 |
| Model Number | IMS-1373 |
| Catalog Number | IMS-1373 |
| Lot Number | 6761 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSSTEX SPS MEDICAL |
| Manufacturer Address | 31 WATER STREET #1 CUBA NY 14727 US 14727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-10 |