MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-04-17 for STIM-U-DENT, MINT manufactured by Johnson & Johnson Consumer Products Co..
[21254134]
Used product by applying to teeth. Product splintered and became stuck in his gums resulting in pain and swelling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648730-2008-00006 |
| MDR Report Key | 1030239 |
| Report Source | 04 |
| Date Received | 2008-04-17 |
| Date of Report | 2008-04-17 |
| Date of Event | 2008-03-26 |
| Date Mfgr Received | 2008-03-27 |
| Date Added to Maude | 2008-04-23 |
| 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 | 3 |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9088742394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STIM-U-DENT, MINT |
| Generic Name | PLAQUE REMOVERS |
| Product Code | JET |
| Date Received | 2008-04-17 |
| Lot Number | 1527P |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 999206 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER PRODUCTS CO. |
| Manufacturer Address | 199 GRANDVIEW RD SKILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-04-17 |