MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-27 for E-2 2802 manufactured by Chattanooga Group.
[1063939]
The patient received three blisters on their heel during a heat therapy, using moist heat pacs. The patient was treated with heat therapy for an unknown injury. The patient completed the treatment with no reported discomfort. A week later, the patient returned for additional therapy and the clinician was informed of the resultant blisters. The assistant could not recall the size of the blisters, treatment details, device details, or conclusion of the incident. The assistant could not confirm the media temperature of the device, which heated the packs. The assistant requested training on the device usage and suggested that a thermometer be included with the device.
Patient Sequence No: 1, Text Type: D, B5
[8179811]
Awaiting return of the device and evaluation. The evaluation results will be reported to the fda - mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2009-00089 |
| MDR Report Key | 1352219 |
| Report Source | 05 |
| Date Received | 2009-03-27 |
| Date of Report | 2009-02-27 |
| Date Mfgr Received | 2009-02-27 |
| Date Added to Maude | 2009-04-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-2 |
| Product Code | IRQ |
| Date Received | 2009-03-27 |
| Model Number | 2802 |
| Catalog Number | 2802 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-27 |