MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-13 for HEAT GUN manufactured by .
[4031110]
I took my daughter to the dentist. They gave her a filling and sealants. They used a heat gun device that had a blue light at the end. After the procedure was over she had a severe burn mark on her cheek next to her mouth. She said she could feel extreme heat but could not speak because her mouth was propped open with a plastic wedge. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033898 |
| MDR Report Key | 3581650 |
| Date Received | 2014-01-13 |
| Date of Report | 2014-01-10 |
| Date of Event | 2014-01-09 |
| Date Added to Maude | 2014-01-22 |
| 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 | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEAT GUN |
| Generic Name | HEAT GUN |
| Product Code | EBZ |
| Date Received | 2014-01-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-13 |