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 CONAIR BODY BENEFITS THPI manufactured by Conair Corp..
[4137706]
Consumer claims the massager to have burned her right inner thigh.
Patient Sequence No: 1, Text Type: D, B5
[11427374]
The original item was tested and no failure was noted with the unit. The product was also not used according to the instruction booklet which was included with the device upon initial sale.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222304-2013-00015 |
| MDR Report Key | 3576735 |
| Report Source | 04 |
| Date Received | 2013-12-30 |
| Date of Report | 2011-11-03 |
| Date of Event | 2011-11-02 |
| Date Mfgr Received | 2011-11-03 |
| Date Added to Maude | 2014-01-16 |
| 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 | CONAIR BODY BENEFITS |
| Generic Name | PROFESSIONAL PERCUSSION MASSAGER |
| Product Code | ISA |
| Date Received | 2013-12-30 |
| Returned To Mfg | 2012-03-01 |
| Model Number | THPI |
| Operator | LAY USER/PATIENT |
| 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 | 1. Other | 2013-12-30 |