MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-19 for ELF LATEX FREE ELASTICS 11/200/16 manufactured by Gac International.
[15998549]
In this event a patient experienced an allergic reaction from an elastomeric used after its expiration date, they reported swelling and irritation to the gingiva and cheek. Medical attention was necessary as the patient was prescribed a steroid.
Patient Sequence No: 1, Text Type: D, B5
[16062591]
While it is unknown if the elastometric in this case caused or contributed to the patient'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. Evaluation of the device found that the product expired in 12/2005.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2418500-2014-00001 |
| MDR Report Key | 3894081 |
| Report Source | 05 |
| Date Received | 2014-06-19 |
| Date of Report | 2014-05-20 |
| Date Mfgr Received | 2014-05-20 |
| Date Added to Maude | 2014-06-26 |
| 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 | SUSQUEHANNA COMMERCE CENTER W 221 W PHILADELPHIA ST, STE 60 |
| 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 | ELF LATEX FREE ELASTICS |
| Product Code | ECI |
| Date Received | 2014-06-19 |
| Returned To Mfg | 2014-05-28 |
| Catalog Number | 11/200/16 |
| Lot Number | 03-42 |
| Device Expiration Date | 2005-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-06-19 |