MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-11-02 for ADHESIVES 500-062 manufactured by Ultradent Products, Inc..
[3027067]
Dr (b)(6) stated that they have had 3 significant enamel fractures in the last 2 weeks and they were all pts with opal seal. This is the only product they have changed in their bonding protocol over the last few yrs and are very concerned. Two pts were wearing clarity (ceramic) and 1 victory (metal) series. (competitor brackets). No further info provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2012-00006 |
| MDR Report Key | 2823485 |
| Report Source | 07 |
| Date Received | 2012-11-02 |
| Date of Report | 2012-11-02 |
| Date of Event | 2012-10-04 |
| Date Mfgr Received | 2012-10-04 |
| Date Added to Maude | 2012-11-28 |
| 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 Street | 10200 SOUTH 505 WEST |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8005525512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADHESIVES |
| Generic Name | BRACKET ADHESIVES RESIN |
| Product Code | DYH |
| Date Received | 2012-11-02 |
| Model Number | 500-062 |
| Catalog Number | 500-062 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS, INC. |
| Manufacturer Address | SOUTH JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2012-11-02 |