MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-19 for DENTEK * manufactured by *.
[17887622]
Family member purchased plastic bag of easy angle floss picks manufactured by: dentek. I only picked up the plastic bag to move it. When i did this, the razor sharp end of one of the floss picks punctured the bag and my finger to the point of bleeding. I was sure i was stuck by a needle. My injury was very minor and stopped bleeding soon without medical help. I am very surprised that someone would make and sell a product like this. Looking at the ends of these floss picks, it is obvious that they can stick the unwarned person, like myself, who was only picking up the bag to move.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040464 |
| MDR Report Key | 762884 |
| Date Received | 2006-09-20 |
| Date of Report | 2006-09-19 |
| Date of Event | 2006-09-19 |
| Date Added to Maude | 2006-09-22 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTEK |
| Generic Name | EASY ANGLE FLOSS PICKS |
| Product Code | JET |
| Date Received | 2006-09-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 750783 |
| Manufacturer | * |
| Manufacturer Address | * MARYSVILLE TN 37801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-20 |