MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-04 for DENTAL MOUTH MIRROR manufactured by Paradise Dental Supplies.
[17975005]
Reporter stated that last week her children received goodie bags during preschool. These bags were handed out by a local dentist. The bags contained a dental mirror and dental floss. On (b)(6) 2011, the reporter stated that her 3 year old began choking and she had to perform the heimlich maneuver. Reporter stated that the mirror came out of the holder and that is what her 3 year old was choking on. Reporter stated there were no markings or warnings on dental mirror.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019653 |
| MDR Report Key | 2010424 |
| Date Received | 2011-03-04 |
| Date of Report | 2011-03-04 |
| Date of Event | 2011-03-01 |
| Date Added to Maude | 2011-03-15 |
| 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 | 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 |
| Generic Name | DENTAL MOUTH MIRROR |
| Product Code | EAX |
| Date Received | 2011-03-04 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARADISE DENTAL SUPPLIES |
| Manufacturer Address | 16251 QUARTER HORSE RD RIVERSIDE CA 92504 US 92504 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-04 |