MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-03 for MOUTH GAG MOLT CHILD * 100-0096 manufactured by Nopa Instruments.
[1019157]
Dentist was working on a special needs pt, who needs the mouth gag to hold open his mouth. The pt moved and pushed the gag out of his mouth causing the tip to come off the instrument. The pt swallowed the tip before the dentist could retrieve it from his mouth, 911 was called, but it was determined that his breathing was fine and he needed no medical attention. The pt passed the tip two days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2008-25840 |
| MDR Report Key | 1262043 |
| Date Received | 2008-12-03 |
| Date of Report | 2008-11-05 |
| Date of Event | 2008-11-03 |
| Date Facility Aware | 2008-11-05 |
| Report Date | 2008-11-17 |
| Date Reported to Mfgr | 2008-11-17 |
| Date Added to Maude | 2008-12-15 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOUTH GAG MOLT CHILD |
| Generic Name | MOUTH GAG MOLT CHILD |
| Product Code | KBN |
| Date Received | 2008-12-03 |
| Model Number | * |
| Catalog Number | 100-0096 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1317698 |
| Manufacturer | NOPA INSTRUMENTS |
| Manufacturer Address | * TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-12-03 |