MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-03-16 for CONAIR CORP JBPB10C manufactured by Conair Corp.
[19295084]
Consumer claims that she placed her feet in the wax and immediately felt her feet burning. She removed her feet from the unit and after drying them she put burn ointment on the bottoms. Her feet are still tingling.
Patient Sequence No: 1, Text Type: D, B5
[19391931]
Complaint is currently being evaluated. Product is being investigated and a supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222304-2014-00037 |
| MDR Report Key | 3763467 |
| Report Source | 04 |
| Date Received | 2014-03-16 |
| Date of Report | 2014-03-19 |
| Date of Event | 2014-03-10 |
| Date Mfgr Received | 2014-03-19 |
| Date Added to Maude | 2014-04-23 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1 CUMMINGS POINT RD. |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONAIR CORP |
| Generic Name | PARAFFIN BATH |
| Product Code | IMC |
| Date Received | 2014-03-16 |
| Model Number | JBPB10C |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONAIR CORP |
| Manufacturer Address | STAMFORD CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-16 |