MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-16 for DAVIS UNK manufactured by Jarit.
[15036933]
Patient complained of tongue pain post surgery. 2 areas of abrasions on each side of tongue secondary to tongue clamp placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 660094 |
| MDR Report Key | 660094 |
| Date Received | 2005-12-16 |
| Date of Report | 2005-08-23 |
| Date of Event | 2005-07-21 |
| Report Date | 2005-08-23 |
| Date Reported to FDA | 2005-12-16 |
| Date Added to Maude | 2006-01-07 |
| 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 | DAVIS |
| Generic Name | MOUTH GAG WITH DAVIS RING MOUTH BLADES |
| Product Code | KBN |
| Date Received | 2005-12-16 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 649525 |
| Manufacturer | JARIT |
| Manufacturer Address | 9 SKYLINE DRIVE HAWTHORNE NY 10532 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-16 |