MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-11-11 for E-1 120V W/PKS 2102 manufactured by Chattanooga Group.
[996354]
Patient received a burn during a heat therapy treatment. Other than being scared by the incident, the patient is ok.
Patient Sequence No: 1, Text Type: D, B5
[8214024]
The customer stated that the device temperature had not been checked since purchase. The device is 5 years old. The customer stated that the device water has a history of being hot. Instruction, per the device manual, was given to the user to remedy the temperature of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00307 |
| MDR Report Key | 1229690 |
| Report Source | 05 |
| Date Received | 2008-11-11 |
| Date of Report | 2008-10-21 |
| Date of Event | 2007-08-20 |
| Date Mfgr Received | 2008-10-21 |
| Date Added to Maude | 2008-11-19 |
| 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-1 120V W/PKS |
| Product Code | IRQ |
| Date Received | 2008-11-11 |
| Model Number | 2102 |
| Catalog Number | 2102 |
| 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 | 1282861 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-11-11 |