MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 1996-10-04 for DAVIS DOUBLE BITE MOUTH GAG N7450 manufactured by Storz Instrument Co..
[16790331]
The weld on this mouth gag is cracked underneath the lever and does not provided tension for ratchet. It will not hold the tongue blade in place. Another mouth gag was used for the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1996-00081 |
| MDR Report Key | 42361 |
| Report Source | 00,06 |
| Date Received | 1996-10-04 |
| Date of Report | 1996-09-06 |
| Date of Event | 1996-08-15 |
| Report Date | 1996-09-06 |
| Date Reported to Mfgr | 1996-09-06 |
| Date Mfgr Received | 1996-09-06 |
| Date Added to Maude | 1996-10-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAVIS DOUBLE BITE MOUTH GAG |
| Generic Name | MOUTH GAG |
| Product Code | KBN |
| Date Received | 1996-10-04 |
| Model Number | NA |
| Catalog Number | N7450 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 43395 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | 499 SOVEREIGN CT ST LOUIS MO 63011 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-04 |