MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-05-26 for CAUTERY TIP, NON-STICK,STRL, 2 DYNJ01200 * manufactured by Medline Industries, Inc..
[383197]
Reportedly the pt received a burn inside and outside the mouth from the cautery tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2005-00008 |
| MDR Report Key | 607803 |
| Report Source | 07 |
| Date Received | 2005-05-26 |
| Date of Report | 2005-05-23 |
| Date of Event | 2005-04-25 |
| Date Mfgr Received | 2005-04-25 |
| Date Added to Maude | 2005-05-31 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARGERET STEPHENS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8479492277 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAUTERY TIP, NON-STICK,STRL, 2 |
| Generic Name | CONMED CAUTERY PENCIL |
| Product Code | HAM |
| Date Received | 2005-05-26 |
| Model Number | DYNJ01200 |
| Catalog Number | * |
| Lot Number | 4048087 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 596020 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | * MUNDELEIN IL * US |
| Baseline Brand Name | CONMED CAUTERY PENCIL AND TIP |
| Baseline Model No | DYNJ01200 |
| Baseline Device Family | CAUT |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-26 |