MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for ACTIFY UNK manufactured by Strauss Diamond Instrument / Strauss & Co..
[126894063]
My orthodontist use a device called "actify" on my bone to make my teeth move faster. I was given a numbing shot during the treatment, but it hurt so bad and never stopped bleeding. My dr said it was because the screw was too big. I have raised area of bone around each place. He used this device and it still hurts now. I have to go to oral surgeon to get checked out. This doesn't seem right to me. I asked the dr for info on the company and safety labels, he showed a tube with a screw with no labels or instructions. This can't be right and safe. Https://straussdiamond. Com/product/actify. This is website for the product that was used on me and i don't think it is a safe product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081133 |
| MDR Report Key | 8046489 |
| Date Received | 2018-11-06 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-10-22 |
| Date Added to Maude | 2018-11-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACTIFY |
| Generic Name | INSTRUMENT, DIAMOND, DENTAL |
| Product Code | DZP |
| Date Received | 2018-11-06 |
| Model Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRAUSS DIAMOND INSTRUMENT / STRAUSS & CO. |
| Manufacturer Address | 14 OFFICE PARK DR STE 8 PALM COAST FL 32137 US 32137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-06 |