MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2009-03-06 for PARACARE 2050 manufactured by Chattanooga Group.
[1081378]
Patients complain of burning sensation when extremities are placed in the paraffin bath containing a different brand of wax. The customer felt that the new wax lacks oil. The customer expressed that the lack of the oil is the source of the burning sensation.
Patient Sequence No: 1, Text Type: D, B5
[8220572]
The customer did not return the device for evaluation. Since the device was not returned for evaluation, no root cause can be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2009-00068 |
| MDR Report Key | 1337143 |
| Report Source | 01,08 |
| Date Received | 2009-03-06 |
| Date of Report | 2009-02-10 |
| Date Mfgr Received | 2009-02-10 |
| Date Added to Maude | 2009-03-12 |
| 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 ROAD |
| 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 | PARACARE |
| Product Code | IMC |
| Date Received | 2009-03-06 |
| Model Number | 2050 |
| Catalog Number | 2050 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2009-03-06 |