MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-06-11 for RELIANCE ORTHODONTIC PRODUCTS LIQUID ETCHANT EL9 manufactured by Reliance Orthodontic Products, Inc..
[2730054]
An orthodontic office called on (b)(6) 2012, stating that the 9 gram liquid etchant used for the preparation of tooth enamel in a bonding procedure was clogged. When excessive force was used to dispense the product, the tip expelled and the contents of the product (containing phosphoric acid) forcefully splashed on the skin of the user. On (b)(6) 2012, the same account contacted reliance orthodontics via the website stating that the user (a chairside assistant) had gotten the product in their eye and required an optometrist for further eval. The user was administered an eye salve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420089-2012-00001 |
| MDR Report Key | 2621165 |
| Report Source | 05 |
| Date Received | 2012-06-11 |
| Date of Report | 2012-06-04 |
| Date of Event | 2012-06-01 |
| Date Mfgr Received | 2012-06-01 |
| Date Added to Maude | 2012-10-10 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAULA WENDLAND, RA MANAGER |
| Manufacturer Street | 1540 WEST THORNDALE AVE. |
| Manufacturer City | ITASCA IL 60143 |
| Manufacturer Country | US |
| Manufacturer Postal | 60143 |
| Manufacturer Phone | 6307734009 |
| Manufacturer G1 | BISCO, INC. |
| Manufacturer Street | 1100 WEST IRVING PARK RD |
| Manufacturer City | SCHAUMBURG IL 60193 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60193 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIANCE ORTHODONTIC PRODUCTS LIQUID ETCHANT |
| Generic Name | PHOSPHORIC ACID ETCHANT |
| Product Code | DYH |
| Date Received | 2012-06-11 |
| Catalog Number | EL9 |
| Lot Number | NOT PROVIDED |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RELIANCE ORTHODONTIC PRODUCTS, INC. |
| Manufacturer Address | 1540 WEST THORNDALE AVE. ITASCA IL 60143 US 60143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-11 |