MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-10-06 for E-2 120V W/PKS 2802 manufactured by Chattanooga Group.
[944136]
The customer purchased the heating unit from a store that went out of business. The reported use of the device was only two times. In 2008, a replacement thermostat was ordered by the customer. Until recently, the customer has used the hot pacs from the heating unit without incident. The customer applied one to the hot pacs to an older lady. The hot pac was applied to the pt's lower back. Upon removing, the hot pac the customer noted redness in the area of treatment. This occurred on six days later.
Patient Sequence No: 1, Text Type: D, B5
[8262614]
The customer did not return the device for eval. Since the device was not returned for eval, no root cause can be determined. Add'l info will be provided via the form 3500a, if required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00284 |
| MDR Report Key | 1190301 |
| Report Source | 04 |
| Date Received | 2008-10-06 |
| Date of Report | 2008-09-15 |
| Date of Event | 2008-09-12 |
| Date Mfgr Received | 2008-09-15 |
| Date Added to Maude | 2008-10-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR 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 120V W/PKS |
| Product Code | IRQ |
| Date Received | 2008-10-06 |
| Model Number | 2802 |
| Catalog Number | 2802 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1230437 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-06 |