MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-24 for RETAINER manufactured by Raintree Essex.
[17387348]
Lips had blisters, peeled, puffed three months, big boils on lips non stop. Went emergency room they didn't know what to do. Dates of use: summer 2007 - (b)(6). Diagnosis or reason for use: retainer - holding teeth in place. Event abated after use stopped or dosage reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037451 |
| MDR Report Key | 3963455 |
| Date Received | 2014-07-24 |
| Date Added to Maude | 2014-07-30 |
| 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 |
| Health Professional | 0 |
| 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 | RETAINER |
| Generic Name | RETAINER |
| Product Code | JEP |
| Date Received | 2014-07-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAINTREE ESSEX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Deathisabilit | 2014-07-24 |