MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-19 for ULTRA FLUID RESISTANT MASKS GCFCXS manufactured by Crosstex International Inc..
| Report Number | 2433773-2020-00003 |
| MDR Report Key | 9853460 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-12-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAUREN JOHNSON |
| Manufacturer Street | 9800 59TH AVE N |
| Manufacturer City | PLYMOUTH, MN |
| Manufacturer Country | US |
| Manufacturer G1 | CROSSTEX INTERNATIONAL INC. |
| Manufacturer Street | 10 RANICK ROAD |
| Manufacturer City | HAPPAUGE, NY |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA FLUID RESISTANT MASKS |
| Generic Name | SURGICAL MASK |
| Product Code | FXX |
| Date Received | 2020-03-19 |
| Model Number | GCFCXS |
| Catalog Number | GCFCXS |
| Lot Number | 201912123,20191212 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSSTEX INTERNATIONAL INC. |
| Manufacturer Address | 10 RANICK ROAD HAPPAUGE, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |