MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-03 for ULTRA? SENSITIVE EARLOOP MASK GCFCXS manufactured by Crosstex International, Inc. A Cantel Medical Comp.
[188139383]
Crosstex received a report through a distributor, (b)(6), that a physician experienced a rash after wearing the crosstex ultra sensitive earloop mask. Crosstex ra followed up with the dental facility at which this incident occurred and they reported the physician had itchiness and a rash around his face and ears within five minutes of applying the mask. The physician had previously worn the same mask and had no reaction. The physician sought medical attention and was prescribed a cortisone cream. The physician has since stopped using the mask and his symptoms have not yet cleared. There have been no other reports of reactions to this mask at the dental facility. The facility did not identify the lot number nor return product for quality analysis. This complaint will be monitored in the crosstex complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[188139384]
Crosstex received a report through a distributor, (b)(6), that a physician experienced a rash after wearing the crosstex ultra sensitive earloop mask.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433773-2020-00001 |
| MDR Report Key | 9779651 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-03 |
| 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 | 9800 59TH AVE N |
| Manufacturer City | PLYMOUTH, MN |
| Manufacturer Country | US |
| Manufacturer G1 | CROSSTEX INTERNATIONAL, INC. A CANTEL MEDICAL COMP |
| Manufacturer Street | 10 RANICK ROAD |
| Manufacturer City | HAUPPAUGE, NY |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA? SENSITIVE EARLOOP MASK |
| Generic Name | SURGICAL MASK |
| Product Code | FXX |
| Date Received | 2020-03-03 |
| Model Number | GCFCXS |
| Catalog Number | GCFCXS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSSTEX INTERNATIONAL, INC. A CANTEL MEDICAL COMP |
| Manufacturer Address | 10 RANICK ROAD HAUPPAUGE,, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-03 |