MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-26 for PROTRACTION FACEMASK 17-100-20 manufactured by Gac International.
[17341950]
In this event it was reported that the pt experienced an allergic reaction to the protration facemask on their chin. No medical attention was necessary and the affected cleared up with in 24 hours.
Patient Sequence No: 1, Text Type: D, B5
[17360214]
While it is unk if the device used in this case caused or contributed to the pt's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2418500-2013-00001 |
| MDR Report Key | 2987613 |
| Report Source | 05 |
| Date Received | 2013-02-26 |
| Date of Report | 2013-01-28 |
| Date Mfgr Received | 2013-01-28 |
| Date Added to Maude | 2013-03-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA STREET, SUITE 60 SUSQUEHANNA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | GAC INTERNATIONAL |
| Manufacturer Street | ONE CA PLAZA SUITE 100 |
| Manufacturer City | ISLANDIA NY 11749 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11749 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTRACTION FACEMASK |
| Product Code | DZB |
| Date Received | 2013-02-26 |
| Returned To Mfg | 2013-02-15 |
| Catalog Number | 17-100-20 |
| Lot Number | 0711 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAC INTERNATIONAL |
| Manufacturer Address | ISLANDIA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-26 |