MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-12-10 for ELF LATEX FREE ELASTICS 11-201-06 manufactured by Dentsply Gac.
[312687]
Pt experienced hives after contact with elastics as part of orthodontic treatment, indicating a possible allergic reaction to the elastics or a component. No medical intervention was reported but it is reasonable to assume from a medical prespective that, at a minimum, the elastics were removed to prevent worsening of symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2086211-2004-00530 |
| MDR Report Key | 559010 |
| Report Source | 04 |
| Date Received | 2004-12-10 |
| Date of Report | 2004-11-10 |
| Date of Event | 2004-11-09 |
| Date Mfgr Received | 2004-11-10 |
| Date Added to Maude | 2004-12-14 |
| 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 | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | SUSQUEHANNA COMMERCE CENTER W. 221 W. PHILA. ST., STE. 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | ORTHODENTAL INTL., INC. |
| Manufacturer Street | 1000 PORTON DR. |
| Manufacturer City | CALEXICO CA 92231 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELF LATEX FREE ELASTICS |
| Generic Name | INTRAORAL ELASTICS |
| Product Code | ECI |
| Date Received | 2004-12-10 |
| Model Number | NA |
| Catalog Number | 11-201-06 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 548704 |
| Manufacturer | DENTSPLY GAC |
| Manufacturer Address | * BOHEMIA NY * US |
| Baseline Brand Name | ELF LATEX FREE ELASTICS |
| Baseline Generic Name | INTRAORAL ELASTICS |
| Baseline Model No | NA |
| Baseline Catalog No | 11-201-06 |
| Baseline ID | NA |
| Baseline Device Family | ELF LATEX FREE ELASTICS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-12-10 |