MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for THE DOCTORS BRUSH PICKS manufactured by .
[130318024]
This serious medical device case reported by email to company refers to a female whose age and allergies were not reported. Consumer had previous dental and bridgework, 3 implants, since she was in her (b)(6). On or about (b)(6) 2018, consumer used the doctors brush picks for dental care and within two days she developed swollen gums, pressure in the gum area, and a small lump on her gum. Consumer was leaving the country so she contacted her dentist for an antibiotic as her "mouth was bothering" her. Amoxicillin was prescribed. Dose and duration of therapy not reported. On an unknown date, consumer had ".. X-rays and a cat scan that did not show anything". Consumer reported that on (b)(6) 2018, she was scheduled for an apicoectomy to help diagnose her issue and she stated, " i have had extensive dental work since my twenties and have never experienced anything like this from a product. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013650481-2018-00004 |
| MDR Report Key | 8162836 |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-09-07 |
| Date Mfgr Received | 2018-11-13 |
| Date Added to Maude | 2018-12-13 |
| 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 | 3 |
| Manufacturer Contact | PV & SAFETY |
| Manufacturer Street | 4615 MURRAY PLACE |
| Manufacturer City | LYNCHBURG VA 24502 |
| Manufacturer Country | US |
| Manufacturer Postal | 24502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THE DOCTORS BRUSH PICKS |
| Generic Name | PICK |
| Product Code | JET |
| Date Received | 2018-12-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-13 |