MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2011-01-10 for RETAINER BRITE CLEANING TABLETS manufactured by Tower Laboratories Ltd..
[21407406]
Consumer states "she feels the retainer brite is making her gums swell". The consumer also stated that "she did not want to seek medical attention and did not want to fill out the pt/allergy questionaire", she just wanted to return the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219540-2011-00002 |
| MDR Report Key | 1961605 |
| Report Source | 07,08 |
| Date Received | 2011-01-10 |
| Date of Report | 2011-01-10 |
| Date Mfgr Received | 2011-01-04 |
| Date Added to Maude | 2011-08-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 8 INDUSTRIAL PARK ROAD |
| Manufacturer City | CENTERBROOK CT 06409 |
| Manufacturer Country | US |
| Manufacturer Postal | 06409 |
| Manufacturer Phone | 8607674881 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RETAINER BRITE CLEANING TABLETS |
| Generic Name | EFFERVESCENT DENTURE CLNR |
| Product Code | JER |
| Date Received | 2011-01-10 |
| Lot Number | 00940-8 |
| Device Expiration Date | 2013-09-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOWER LABORATORIES LTD. |
| Manufacturer Address | CENTERBROOK CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Other | 2011-01-10 |