MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-22 for GUM RED-COTE manufactured by .
[25911034]
My almost (b)(6) daughter ate part of a gum red-cote tablet and had an adverse anaphylactic reaction. She had swelling of her lips and tongue, hives, and an asthma attack. We treated her with benadryl and albuterol sulfate via nebulizer and they brought her symptoms under control. Dates of use: 1 use. Diagnosis or reason for use: tooth brushing aid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056129 |
| MDR Report Key | 5077501 |
| Date Received | 2015-07-22 |
| Date of Report | 2015-07-22 |
| Date of Event | 2015-07-21 |
| Date Added to Maude | 2015-09-15 |
| 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 | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GUM RED-COTE |
| Generic Name | GUM RED-COTE |
| Product Code | NYH |
| Date Received | 2015-07-22 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-07-22 |