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 2019-05-30 for NATURAL EXTENSIONS EXTRA SENSITIVE EAR LOOP FACE MASK GPLUSWHB manufactured by Crosstex International Inc..
[146628388]
(b)(4), distributor of natural extensions extra sensitive ear loop face mask, reported that a dental hygienist experienced symptoms of an allergic reaction while wearing the face mask. Crosstex followed up with the facility for additional information. It was reported the hygienist experienced symptoms of a hot, irritating sensation on her face. It was reported that the symptoms have been ongoing since (b)(6) 2018 with the use of several different face masks. It is unknown if all masks used were manufactured by crosstex. The hygienist is currently under medical supervision. The facility reported that the hygienist has a pre-existing condition (shingles) and multiple allergies. This complaint will continue to be monitored in the crosstex complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[146628389]
(b)(4), distributor of natural extensions extra sensitive ear loop face mask, reported that a dental hygienist experienced symptoms of an allergic reaction while wearing the face mask.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433773-2019-00003 |
| MDR Report Key | 8655941 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-05-01 |
| Date Added to Maude | 2019-05-30 |
| 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 | HANNAH SHRADER |
| Manufacturer Street | 10 RANICK ROAD |
| Manufacturer City | HAUPPAUGE NY 22788 |
| Manufacturer Country | US |
| Manufacturer Postal | 22788 |
| Manufacturer Phone | 7635596863 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATURAL EXTENSIONS EXTRA SENSITIVE EAR LOOP FACE MASK |
| Generic Name | SURGICAL MASK |
| Product Code | FXX |
| Date Received | 2019-05-30 |
| Model Number | GPLUSWHB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-05-30 |