MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-10 for CURETTE manufactured by Miltex Instrument Co, Inc..
[18653]
Curette is inappropriate due to its shank being too long causing trauma to surrounding tissue. The prophy technicians also have difficulty placing the instrument between the teeth (due to shank being too wide) thus causes pt discomfort and does not allow adequate cleaning due to inability to achieve proper angle of shank to tooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001189 |
| MDR Report Key | 32912 |
| Date Received | 1996-05-10 |
| Date of Report | 1995-08-02 |
| Date Added to Maude | 1996-05-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURETTE |
| Generic Name | CURETTE |
| Product Code | EMN |
| Date Received | 1996-05-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34211 |
| Manufacturer | MILTEX INSTRUMENT CO, INC. |
| Manufacturer Address | LAKE SUCCESS NY * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-10 |