MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-05-08 for MOUTH GAG MOLT CHILD 100-0096 manufactured by Nopa Instruments.
[1204092]
Doctor was using the mouth gag on a (b) (6) female patient when the rubber tip came off and rolled to the back of the patient's mouth. The patient was not hurt and the tip was retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2009-00002 |
| MDR Report Key | 1386833 |
| Report Source | 99 |
| Date Received | 2009-05-08 |
| Date of Report | 2009-04-08 |
| Date of Event | 2009-04-08 |
| Date Facility Aware | 2009-04-08 |
| Report Date | 2009-05-07 |
| Date Reported to FDA | 2009-05-07 |
| Date Reported to Mfgr | 2009-05-07 |
| Date Added to Maude | 2010-03-02 |
| 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 |
| Manufacturer Street | 41 WEAVER RD. |
| Manufacturer City | DENVER PA 17517 |
| Manufacturer Country | US |
| Manufacturer Postal | 17517 |
| Manufacturer G1 | HENRY SCHEIN, INC. |
| Manufacturer Street | 41 WEAVER RD. |
| Manufacturer City | DENVER PA 17517 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17517 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOUTH GAG MOLT CHILD |
| Generic Name | MOUTH GAG MOLT CHILD |
| Product Code | KBN |
| Date Received | 2009-05-08 |
| Catalog Number | 100-0096 |
| Lot Number | 0305P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOPA INSTRUMENTS |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-05-08 |