MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2019-10-23 for CROSSTEX ULTRA SENSITIVE EARLOOP GCFCXS manufactured by Crosstex International Inc..
| Report Number | 2433773-2019-00005 |
| MDR Report Key | 9224368 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2019-10-23 |
| Date of Report | 2019-10-23 |
| Date of Event | 2019-10-03 |
| Date Added to Maude | 2019-10-23 |
| 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 | ANN MOUA |
| Manufacturer Street | 10 RANICK RD |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal | 11788 |
| Manufacturer Phone | 7633182956 |
| Manufacturer G1 | CROSSTEX INTERNATIONAL INC. |
| Manufacturer Street | 10 RANICK RD |
| Manufacturer City | HAUPPAUGE NJ 11788 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11788 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CROSSTEX ULTRA SENSITIVE EARLOOP |
| Generic Name | CROSSTEX SURGICAL MASK |
| Product Code | FXX |
| Date Received | 2019-10-23 |
| Model Number | GCFCXS |
| Catalog Number | GCFCXS |
| Lot Number | 20190624 |
| 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 HAUPPAUGE NY 11788 US 11788 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-23 |