MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for CEMENT manufactured by Unk.
[179296326]
Pt called to report an adverse reaction to a cement used while getting a temporary crown. Pt stated that on (b)(6) 2019, she had her first appt for a temporary crown and believes she had a reaction to the cement used. Pt said she experienced small sores inside her mouth. Pt stated she went back on (b)(6) 2019, and the dental assistant told her they were going to give her stronger cement. Pt said her reaction got worse, inside her mouth was inflamed, the veins in her mouth became swollen, she was cold and shaky, and had chest pain. Pt suspects the cement is what caused her adverse reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092950 |
| MDR Report Key | 9699781 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2019-10-31 |
| Date Added to Maude | 2020-02-12 |
| 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 |
| 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 | 3 |
| Brand Name | CEMENT |
| Generic Name | CEMENT, DENTAL |
| Product Code | EMA |
| Date Received | 2020-02-11 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-11 |