MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-01 for HOT PACK HEATER SS 21571 manufactured by Chattanooga Corp..
[21241]
On 11/20/95 pt was placed in supine position with hydroculator packs on anterior knee joint with appropriate padding. Interferential stimulation to quadriceps femoris and anterior knee joint was initiated. Pt did not report any ill effects. Equipment was removed. On 11/21/95 pt called office and indicated that a blister had formed and physician had evaluated the burn. An incident report was filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 31299 |
| MDR Report Key | 31299 |
| Date Received | 1996-02-01 |
| Date of Report | 1995-12-01 |
| Date of Event | 1995-11-20 |
| Date Facility Aware | 1995-11-21 |
| Report Date | 1995-12-01 |
| Date Added to Maude | 1996-03-21 |
| 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 | HOT PACK HEATER |
| Generic Name | HYDROCULATOR |
| Product Code | IRQ |
| Date Received | 1996-02-01 |
| Model Number | SS |
| Catalog Number | 21571 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32369 |
| Manufacturer | CHATTANOOGA CORP. |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-02-01 |