MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-20 for HYDROCOLLATOR M-2 * manufactured by Chattanooga Group, Inc..
[82710]
Pt suffered second degree burn to the right shoulder after a hot pack therapy. Hot pack was heated in a hydrocollator set at 170 degrees fahrenheit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 193325 |
| MDR Report Key | 193325 |
| Date Received | 1998-10-20 |
| Date of Report | 1998-10-19 |
| Date of Event | 1998-08-25 |
| Date Facility Aware | 1998-08-26 |
| Report Date | 1998-10-19 |
| Date Added to Maude | 1998-10-27 |
| 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 | HYDROCOLLATOR |
| Generic Name | HEATING UNIT / STEAM PACKS |
| Product Code | IRQ |
| Date Received | 1998-10-20 |
| Model Number | M-2 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 120 VOLTS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 187846 |
| Manufacturer | CHATTANOOGA GROUP, INC. |
| Manufacturer Address | 4717 ADAM RD PO BOX 489 HIXON TN 373630489 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 9 | 1. Other | 1998-10-20 |