MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-01-22 for TOUCH N TONE MASSAGER WITH MAGNET ATTACHMENT HM11M manufactured by Conair Corp..
[17260629]
Consumer claims she was burned from the cord being damaged and also she had the unit off on her bed and when she rolled over she must have hit the switch and it turned on, burning her left upper leg.
Patient Sequence No: 1, Text Type: D, B5
[17367546]
In testing now. Will resubmit to fda and send updated info at a later date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222304-2014-00003 |
| MDR Report Key | 3588188 |
| Report Source | 04 |
| Date Received | 2014-01-22 |
| Date of Report | 2013-09-26 |
| Date of Event | 2013-08-26 |
| Date Mfgr Received | 2013-09-26 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2014-02-26 |
| 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 06904 |
| Manufacturer Country | US |
| Manufacturer Postal | 06904 |
| Manufacturer Phone | 2033519469 |
| Manufacturer G1 | CONAIR CORP. |
| Manufacturer Street | 1 CUMMINGS POINT RD. |
| Manufacturer City | STAMFORD CT 06904 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06904 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOUCH N TONE MASSAGER WITH MAGNET ATTACHMENT |
| Generic Name | HM11M |
| Product Code | ISA |
| Date Received | 2014-01-22 |
| Returned To Mfg | 2013-10-11 |
| Model Number | HM11M |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONAIR CORP. |
| Manufacturer Address | 1 CUMMINGS POINT RD. STAMFORD CT 06904 US 06904 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-22 |