MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-02 for KROGER MTH GD RST ASRD W/TRAY 2CT MTH GD RST ASRD W/TRAY 2CT CD manufactured by Ranir Llc.
[126224532]
Consumer stated she purchased night guard in order to protect her invisalign. After using your product, she claims that she developed a throat infection. She said she hasn't had any issues with any other products except for yours. Her doctor gave her an antibiotic and she thought that maybe she could try it again after being on antibiotics for 10 days. She tried it again one night and it irritated my throat and she had to take it out in the middle of the night. She said "i'm a pretty healthy person, i can't imagine i just develop a throat infection for no reason. I think it's your product. " update (b)(6) 2018 her doctor said she didn't have a staph infection just an "allergic reaction". Even though she had this reaction, she has still been wearing the guard because she wears the invisalign and doesn't want to grind that down. She purchased this the end of (b)(6), and has been using it for a few weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2018-00445 |
| MDR Report Key | 8034937 |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-10-23 |
| Date Facility Aware | 2018-10-23 |
| Date Mfgr Received | 2018-10-23 |
| Date Added to Maude | 2018-11-02 |
| 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 | KROGER MTH GD RST ASRD W/TRAY 2CT |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2018-11-02 |
| Model Number | MTH GD RST ASRD W/TRAY 2CT CD |
| 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 | 2018-11-02 |