MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-29 for GUM PICKS manufactured by Dentek Oral Care Products.
[56450277]
Product mfr: dentek oral care products. Dentek sells plastic gum picks, to clear food from between teeth. There are several other manufacturers of this type of product. The dentek gum picks have a soft bristle shaft and point, and a flexible tip. The tip breaks off in your mouth, and the plastic tip can be swallowed. My doctor indicates this is not good for the digestive system, as the tip is sharp. Regularly, the tips break off in our mouths. I tried to contact dentek to voice my complaint, but their help line does not answer with a live person, and messages to them have not been returned. Further, they have an online complaint form third party, but the company dentek is not even listed on the form to direct the complaint. Document number: (b)(4), report number: (b)(4). Retailer: drug store, retailer state: (b)(6), purchase date: (b)(6) 2016, this date is an estimate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065124 |
| MDR Report Key | 5993292 |
| Date Received | 2016-09-29 |
| Date of Report | 2016-09-21 |
| Date of Event | 2016-09-21 |
| Date Added to Maude | 2016-10-03 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GUM PICKS |
| Generic Name | GROOMING |
| Product Code | JET |
| Date Received | 2016-09-29 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTEK ORAL CARE PRODUCTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-29 |