MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-03 for M-2 2402-2403-2404 2402-2404 manufactured by Chattanooga Group, Inc..
[20922537]
Broken thermostat in hydrocollator unit causing temperature to rise above the recommended operating range resulting in first degree burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 617984 |
| MDR Report Key | 617984 |
| Date Received | 2005-06-03 |
| Date of Report | 2005-06-03 |
| Date of Event | 2005-05-05 |
| Report Date | 2005-06-03 |
| Date Reported to FDA | 2005-06-03 |
| Date Added to Maude | 2005-06-30 |
| 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 | M-2 |
| Generic Name | HYDROCOLLATOR |
| Product Code | IRQ |
| Date Received | 2005-06-03 |
| Model Number | 2402-2403-2404 |
| Catalog Number | 2402-2404 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 607670 |
| Manufacturer | CHATTANOOGA GROUP, INC. |
| Manufacturer Address | 4717 ADAMS ROAD HIXSON TN 37343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-03 |