MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-10-03 for 50-3895 T & A CUSTOM KIT -4/CS manufactured by Deroyal.
[169451]
During a t&a, the physician fired the cautery pencil and it flamed in the pt's throat. Md saw this in time to prevent pt injury. Immediately, pencil was given to o. R. Risk mgr. , who reported the incident by phone to mfr. One (1) each affected and will be returned to mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034876-2000-00005 |
| MDR Report Key | 299463 |
| Report Source | 00 |
| Date Received | 2000-10-03 |
| Date of Report | 2000-10-02 |
| Date of Event | 2000-09-01 |
| Date Mfgr Received | 2000-09-01 |
| Date Added to Maude | 2000-10-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 185 RICHARDSON WAY |
| Manufacturer City | MAYNARDVILLE TN 37807 |
| Manufacturer Country | US |
| Manufacturer Postal | 37807 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 50-3895 T & A CUSTOM KIT -4/CS |
| Generic Name | CTH CUSTOM PROCEDURAL TRAY E.E.N.T |
| Product Code | MMO |
| Date Received | 2000-10-03 |
| Catalog Number | 50-3895 |
| Lot Number | 489193 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 289864 |
| Manufacturer | DEROYAL |
| Manufacturer Address | 200 DEBUSK LN POWELL TN 37849 US |
| Baseline Brand Name | T & A CUSTOM KIT |
| Baseline Generic Name | CUSTOM PROCEDURAL TRAY |
| Baseline Model No | NA |
| Baseline Catalog No | 50-3895 |
| Baseline ID | NA |
| Baseline Device Family | TRAY SURGICAL ENT |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-03 |