MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-18 for REPLACEMENT CARBIDE TIP FOR AEZ ADHESIVE REMOVING PLIER 803-0975 manufactured by Ormco Corporation.
[2363238]
On (b)(6) 2011, a doctor alleged that the replacement carbide tips for the aez adhesive removing plier were dulling and breaking. There were no injuries associated with regard to this incident; however, it was alleged that in the past, due to the dull tips, patient's enamel have chipped upon removing the excess cement.
Patient Sequence No: 1, Text Type: D, B5
[9463396]
The complainant alleged that the replacement carbide tips for the aez adhesive removing plier were dulling and breaking. There were no injuries associated with regard to this incident; however, it was alleged that in the past, due to the dull tips, patient's enamel have chipped upon removing the excess cement. There were no previous incidents reported by this complainant with regard to this product. The doctor repaired the chipped enamel during the same visit without further incident. The complainant was not definitive as to the number of patients affected; therefore, one (1) mdr is being submitted for the alleged serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2011-00208 |
| MDR Report Key | 2342798 |
| Report Source | 05 |
| Date Received | 2011-11-18 |
| Date of Report | 2011-10-19 |
| Date of Event | 2011-10-19 |
| Date Mfgr Received | 2011-10-19 |
| Date Added to Maude | 2011-11-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPLACEMENT CARBIDE TIP FOR AEZ ADHESIVE REMOVING PLIER |
| Generic Name | PLIER, ORTHODONTIC |
| Product Code | JEX |
| Date Received | 2011-11-18 |
| Catalog Number | 803-0975 |
| Lot Number | UNKNOWN |
| Operator | OTHER |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2011-11-18 |