MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-02-27 for STIMUDENT PLAQUE REMOVER manufactured by Johnson & Johnson Healthcare Products.
[16405524]
A female broke out in mouth area after using product. Symptoms did not abate after she discontinued using the product. She saw a doctor, had surgery. Symptom suggest hypersensitivity reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648730-2008-00002 |
| MDR Report Key | 1004062 |
| Report Source | 04 |
| Date Received | 2008-02-27 |
| Date of Report | 2008-01-28 |
| Date of Event | 2006-07-04 |
| Date Facility Aware | 2008-01-28 |
| Date Added to Maude | 2008-03-04 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9088742394 |
| Manufacturer G1 | JOHNSON & JOHNSON ORTHOPAEDICS |
| Manufacturer City | LAS PIEDRAS PR |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STIMUDENT PLAQUE REMOVER |
| Generic Name | INTERDENTAL PLAQUE REMOVER PICKS |
| Product Code | JET |
| Date Received | 2008-02-27 |
| Model Number | NA |
| Catalog Number | NA |
| 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 | 973327 |
| Manufacturer | JOHNSON & JOHNSON HEALTHCARE PRODUCTS |
| Manufacturer Address | 199 GRANDVIEW RD SKILLMAN NJ 085558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-27 |