MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-30 for DENTAL CAP SCAN manufactured by Unk.
[4673343]
The reporter had several problems at various stages over the next 3 weeks. She had a day of tingling in the mouth and throat that lasted for several days, pain and tingling at the base of her teeth that was significant but did not last a long. Also had swollen saliva glands. The day following the scan her nose was running like a faucet. Also had difficulty swallowing especially capsules and tablets, shortness of breath and her throat felt swollen. This lasted for about 3 weeks. Also had a problem with muscular control; difficulty walking and lifting objects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036896 |
| MDR Report Key | 3905583 |
| Date Received | 2014-06-30 |
| Date of Report | 2014-06-30 |
| Date of Event | 2014-05-23 |
| Date Added to Maude | 2014-07-02 |
| 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 |
| Health Professional | 3 |
| 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 | DENTAL CAP SCAN |
| Generic Name | DENTAL SCAN |
| Product Code | NOF |
| Date Received | 2014-06-30 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-30 |