MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-21 for GAC NON LETEC ELESTICS 11-303-03 manufactured by Gac International.
[5855996]
In this event it was reported that between two or three weeks after exposure to gac elastics (non-latex), a pt began experiencing buring and itching of the lips and eyes. The pt took benadryl to combat the symptoms.
Patient Sequence No: 1, Text Type: D, B5
[13298516]
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 responses and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr park 803. The device is available for eval, though results are not available as of this report. Eval results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2418500-2015-00001 |
| MDR Report Key | 4795832 |
| Report Source | 05 |
| Date Received | 2015-05-21 |
| Date of Report | 2015-04-22 |
| Date Mfgr Received | 2015-04-22 |
| Date Added to Maude | 2015-05-27 |
| 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 ST, STE 60 SUSQUEHANNA COMMERCE CTR W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAC NON LETEC ELESTICS |
| Generic Name | BAND, ELASTIC, ORTHODONTIC |
| Product Code | ECI |
| Date Received | 2015-05-21 |
| Returned To Mfg | 2015-05-21 |
| Catalog Number | 11-303-03 |
| Lot Number | 316739 |
| Device Expiration Date | 2016-03-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Required No Informationntervention | 2015-05-21 |