MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-08-10 for EFFERGRIP DENTURE ADHESIVE CREAM / ZINC FREE UNK manufactured by Medtech Products, Inc..
[23085279]
An (b)(6) female consumer reported experiencing a burning sensation, pain, dentures fell out of her mouth, lack of effect, restless and sleepless throughout the night, and fluctuating consciousness while using effergrip denture adhesive cream / zinc free formula. On 06/17/2015, the consumer reported using one application, amount unk, twice of effergrip denture adhesive cream / zinc free formula. After starting effergrip denture cream / zinc free formula, she experienced a burning sensation, pain, dentures fell out of her mouth, lack of effect, and restless and sleepless throughout the night. On 06/18/2015, she experienced fluctuating consciousness, almost incoherent, while putting soap and water on a paper towel and attempting to rinse her gums to relieve the hot burning sensation. The next morning, her husband called the emt and she went to the emergency room. The consumer is currently taking medications daily, however, they are unspecified. Her medical history is unk and she was not pregnant at the time of incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002647523-2015-00002 |
| MDR Report Key | 4995443 |
| Report Source | CONSUMER |
| Date Received | 2015-08-10 |
| Date of Report | 2015-07-30 |
| Date of Event | 2015-06-17 |
| Date Mfgr Received | 2015-07-16 |
| Device Manufacturer Date | 2014-04-21 |
| Date Added to Maude | 2015-08-12 |
| 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 Street | 660 WHITE PLAINS RD |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145248700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EFFERGRIP DENTURE ADHESIVE CREAM / ZINC FREE |
| Generic Name | DENTURE ADHESIVE CREAM, OTC |
| Product Code | KOL |
| Date Received | 2015-08-10 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 4D1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTECH PRODUCTS, INC. |
| Manufacturer Address | TARRYTOWN NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-10 |