MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-29 for WALGREENS LOST FILLING AND LOOSE CAP REPAIR manufactured by .
[134399743]
This serious case reports a (b)(6) year old male using walgreens lost filling & loose cap repair on deteriorating teeth. He has a medical history of throat and mouth cancer. He reported tooth decay related to radiation and chemotherapy treatments. On (b)(6) 2018, the consumer used walgreens lost filling & loose cap repair for management of ongoing tooth decay and experienced mouth burning, blisters in mouth, throat swelling, pain and sores in mouth. He reported using this product in the past from walgreens as well as other brands and did not experience any type of reaction. The consumer reported removing the product from the mouth. Due to the reaction to this product, he was unable to eat for a week. He was taken to a local emergency department to get stabilized. Treatments required to stabilized consumer were not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006644229-2019-00002 |
| MDR Report Key | 8286457 |
| Report Source | CONSUMER |
| Date Received | 2019-01-29 |
| Date of Report | 2019-01-29 |
| Date of Event | 2018-11-19 |
| Date Mfgr Received | 2019-01-08 |
| Date Added to Maude | 2019-01-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PRESTIGE BRANDS PV & SAFETY |
| Manufacturer Street | 4615 MURRAY PLACE |
| Manufacturer City | LYNCHBURG VA 24502 |
| Manufacturer Country | US |
| Manufacturer Postal | 24502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALGREENS LOST FILLING AND LOOSE CAP REPAIR |
| Generic Name | CEMENT, DENTAL |
| Product Code | EMA |
| Date Received | 2019-01-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2019-01-29 |