MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-14 for STIM-U-DENT * manufactured by Johnson & Johnson Consumer Product, Inc..
[49604]
The product splinters and breaks off when used as directed. The rptr is concerned that a pt could swallow or choke. He also feels that if pieces of the product got caught in the gums, it could cause infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001806 |
| MDR Report Key | 76548 |
| Date Received | 1997-03-14 |
| Date of Report | 1997-03-10 |
| Date Added to Maude | 1997-03-19 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | STIM-U-DENT |
| Generic Name | INTERDENTAL STIMULATOR |
| Product Code | JET |
| Date Received | 1997-03-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 76272 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER PRODUCT, INC. |
| Manufacturer Address | RANDVIEW RD SKILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-14 |