MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-04 for PLACKERS PKFL APPL CNNMN 60CT LMTD ED manufactured by Ranir Llc.
[137732075]
Consumer believed she was having an allergic reaction to the cinnamon apple flosser and asked if there were any natural cinnamon oils in the product. Confirmed with consumer that the flavoring was artificial. Consumer stated this is the first time using the product. She "noticed some burning and irritation in my mouth after using the flossers for a few days. The symptoms went away after a couple days of stopping using the product. I seem to have developed some random oral allergies in the last few years (i am (b)(6) now)- i used mint and other plant based products when i was younger with no problems. I also have some chemical sensitivities to different lotions and topical skin products now- i'm not sure what all of the irritants are yet- this also has only happened to me in the last few years... I generally have been doing ok if i avoid products with plant oils in them such as mint- but then sometimes lotions with only synthetic ingredients bother me"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2019-00519 |
| MDR Report Key | 8387444 |
| Report Source | CONSUMER |
| Date Received | 2019-03-04 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-02-13 |
| Date Facility Aware | 2019-02-13 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-03-04 |
| 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 Contact | REBEKAH STENSKE |
| Manufacturer Street | 4701 EAST PARIS AVE. SE |
| Manufacturer City | GRAND RAPIDS MI 495125353 |
| Manufacturer Country | US |
| Manufacturer Postal | 495125353 |
| Manufacturer Phone | 6166988880 |
| Manufacturer G1 | RANIR LLC |
| Manufacturer Street | 4701 EAST PARIS AVE. SE |
| Manufacturer City | GRAND RAPIDS MI 495125353 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 495125353 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLACKERS |
| Generic Name | FLOSS, DENTAL |
| Product Code | JES |
| Date Received | 2019-03-04 |
| Model Number | PKFL APPL CNNMN 60CT LMTD ED |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RANIR LLC |
| Manufacturer Address | 4701 EAST PARIS AVE. SE GRAND RAPIDS MI 495125353 US 495125353 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-04 |