MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-12-30 for WATER FALL FB52K manufactured by Conair Corp..
[21657784]
Customer filled the unit with water and plugged it in the wall. Twenty seconds later, it shocked him. He was shocked when he pressed the light and heat button.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2013-00013 |
| MDR Report Key | 3576809 |
| Report Source | 04 |
| Date Received | 2013-12-30 |
| Date of Report | 2013-08-11 |
| Date of Event | 2013-08-10 |
| Date Mfgr Received | 2013-08-11 |
| Date Added to Maude | 2014-01-28 |
| 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 Street | 1 CUMMINGS POINT RD. |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Manufacturer Phone | 2033519469 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER FALL |
| Generic Name | FOOT BATH |
| Product Code | ISA |
| Date Received | 2013-12-30 |
| Model Number | FB52K |
| 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 | CONAIR CORP. |
| Manufacturer Address | STAMFORD CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-30 |