MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-25 for PLACKERS PKFL TWN LN MNT 150 manufactured by Ranir Llc.
[138090766]
Consumer stated he/she had been a long time user of plackers twin line flossers she recently purchased a new pack at (b)(6) and immediately noticed that the plastic material used is different. "it? S stiff and less pliable and when flip down the toothpick it often breaks off as the material doesn't bend well. Right off i noticed hearing/feeling a? Snap? Like breaking noise on the first bend? Then after 2 or 3 bends it often breaks off on one or both sides? This is not something i experienced in prior years of using and can say it almost never became detached. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2019-00508 |
| MDR Report Key | 8368329 |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-01-30 |
| Date Facility Aware | 2019-01-30 |
| Date Mfgr Received | 2019-01-30 |
| Date Added to Maude | 2019-02-25 |
| 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 | 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 | 0 |
| Brand Name | PLACKERS |
| Generic Name | FLOSS, DENTAL |
| Product Code | JES |
| Date Received | 2019-02-25 |
| Returned To Mfg | 2019-02-11 |
| Model Number | PKFL TWN LN MNT 150 |
| Lot Number | 8197A |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-02-25 |