MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-24 for PARA-CARE 120V PKG. 2050 manufactured by Chattanooga Group.
[19543639]
Clinician noted a strong burning smell from one of the treatment rooms. The clinician investigated and found that a paracare was the source of the burning smell. Upon evaluation of the paracare device, the clinician noted that paracare wax had turned brown. The clinician also noted the appearance of a hole in the bottom of the device. The clinician removed the device from service. No injury occurred with the device.
Patient Sequence No: 1, Text Type: D, B5
[19667587]
The device has been received and is currently under evaluation. The device evaluation and any additional findings will be provided upon conclusion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00301 |
| MDR Report Key | 1215480 |
| Report Source | 05 |
| Date Received | 2008-10-24 |
| Date of Report | 2008-10-02 |
| Date of Event | 2008-10-02 |
| Date Mfgr Received | 2008-10-02 |
| Date Added to Maude | 2009-06-02 |
| 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 | PARA-CARE 120V PKG. |
| Product Code | IMC |
| Date Received | 2008-10-24 |
| Returned To Mfg | 2008-10-16 |
| Model Number | 2050 |
| Catalog Number | 2050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2008-10-24 |