MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-13 for STORZ MOUTH GAG SIDE BITE N7435 * manufactured by Storz.
[20093299]
Doctor was inserting the side bite and opening the jaws when it broke into three pieces. The equipment was sent for repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2663890 |
| MDR Report Key | 2663890 |
| Date Received | 2012-07-13 |
| Date of Report | 2012-07-09 |
| Date of Event | 2012-07-06 |
| Report Date | 2012-07-09 |
| Date Reported to FDA | 2012-07-13 |
| Date Added to Maude | 2012-07-20 |
| 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 | 3 |
| 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 | STORZ MOUTH GAG SIDE BITE |
| Generic Name | GAG, MOUTH |
| Product Code | KBN |
| Date Received | 2012-07-13 |
| Model Number | N7435 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STORZ |
| Manufacturer Address | 2151 EAST GRAND AVENUE EL SEQUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-13 |