MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-07 for ULTRA SENSITIVE EARLOOP W/ SECURE FIT FACE MASK GCFCXSSF manufactured by Crosstex International Inc..
[119514781]
A dental office reported that a hygienist at the facility experienced allergic reaction symptoms after wearing a crosstex ultra sensitive secure fit face mask for the first time. The dental office contacted crosstex to report the reaction and was provided the technical data sheet for mask materials information. Crosstex followed up with the facility for more information on the reported reaction. It was reported the hygienist took benadryl right away and had experienced symptoms of red skin, confusion and irritation, difficulty breathing, swollen tongue and difficulty swallowing. The facility contacted paramedics who provided oxygen. It was reported the hygienist did not experience any lasting symptoms and her current condition is fine. Other personnel in the office have worn the same face masks without any reactions. A review of the device history record indicates the mask was manufactured per crosstex specifications and no issues were noted. Crosstex has not received any similar complaints for this lot. This complaint will continue to be monitored in the crosstex complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[119514782]
A dental office reported that a hygienist experienced allergic reaction symptoms, including anaphylaxis, while wearing a crosstex ultra sensitive secure fit face mask for the first time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433773-2018-00003 |
| MDR Report Key | 7855043 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-07 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-08-17 |
| Date Mfgr Received | 2018-08-17 |
| Device Manufacturer Date | 2018-02-15 |
| Date Added to Maude | 2018-09-07 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SADIE MARTIN |
| Manufacturer Street | 10 RANICK ROAD |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal | 11788 |
| Manufacturer G1 | CROSSTEX INTERNATIONAL INC. |
| Manufacturer Street | 10 RANICK ROAD |
| Manufacturer City | HAUPPAUGE NY 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 | ULTRA SENSITIVE EARLOOP W/ SECURE FIT FACE MASK |
| Generic Name | SURGICAL MASK |
| Product Code | FXX |
| Date Received | 2018-09-07 |
| Model Number | GCFCXSSF |
| Lot Number | 20180215 |
| 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 | 2018-09-07 |