MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-25 for CROWE-DAVIS #2 RIGHT * manufactured by *.
[20468378]
Mouth gag broke in pt's mouth during t&a surgery- child suffered no ill effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 152008 |
| MDR Report Key | 152008 |
| Date Received | 1998-02-25 |
| Date of Report | 1998-02-24 |
| Date of Event | 1998-02-18 |
| Date Facility Aware | 1998-02-18 |
| Report Date | 1998-02-24 |
| Date Reported to FDA | 1998-02-24 |
| Date Added to Maude | 1998-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | CROWE-DAVIS |
| Generic Name | MOUTH GAG |
| Product Code | KBN |
| Date Received | 1998-02-25 |
| Model Number | #2 RIGHT |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 148132 |
| Manufacturer | * |
| Manufacturer Address | * SALT LAKE CITY UT * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-02-25 |