MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-13 for RETAINERS UPPER AND BOTTOM RED, CLEAR PLASTIC AND METAL manufactured by Unk.
[19406908]
Started wearing the retainers (b)(6) 2014 became very ill (b)(6) 2014. Made in doctors office would not give me any information who made the retainers. Frequency: daily bedtime, eat with it in mouth. How was it taken or used: mouth - teeth. Why was the person using the product: keep teeth in place. When i begin wearing the retainers i became very ill. I went to three doctors and urgent care. Each doctor and nurse gave me medication. When i went to the third doctor the medication helped a little. I am going to a fourth doctor. I believe the retainers need to be tested, i believe there might be chemical toxicity on the retainers, or toxicity poison. I need to know if there are chemicals or toxic. Poisons on these retainers, if there is the doctors will know what type of medication to prescribe so my body can heal. I stopped wearing the retainers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040785 |
| MDR Report Key | 4531305 |
| Date Received | 2015-02-13 |
| Date of Report | 2015-02-04 |
| Date of Event | 2014-12-27 |
| Date Added to Maude | 2015-02-23 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RETAINERS UPPER AND BOTTOM RED, CLEAR PLASTIC AND METAL |
| Generic Name | RETAINERS UPPER AND BOTTOM RED, CLEAR PLASTIC AND METAL |
| Product Code | DYJ |
| Date Received | 2015-02-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2015-02-13 |