N
Patient 1
DEVICE NOT RETURNED TO MANUFACTURER.
MAUDE MDR 5070431
- MDR report key
- 5070431
- Report number
- 1222304-2015-00017
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-08-13
- Date received
- 2015-09-11
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS NINA RUIZ
- Address
- 1 CUMMINGS POINT RD STAMFORD CT 06902 US
- Phone
- 203-203-2033
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CONAIR HEATING MASSAGER | HEATING MASSAGER | CONAIR CORPORATION | ISA | THP2 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-09-11 | 0 | 1. O |
Event Narratives#
D
Patient 1
CONSUMER STATE SHE WAS DOZING WHEN SHE WAS USING HER MASSAGER. SHE CLAIMS SHE DIDN'T FEEL THE HEAT. SHE TURNED UNIT OFF, NOT UNPLUGGED AND NOTICED IT SMELLED. WHEN SHE FELT IT , IT WAS EXTREMELY HOT. SHE TAKES PAIN MEDICATION. SHE RECEIVED MEDICAL ATTENTION THE DAY AFTER THE INCIDENT. THE MASSAGER IS A DISCONTINUED PRODUCT.
N
Patient 1
THE UNIT WAS RETURNED BY THE CONSUMER AND WAS TESTED AND EVALUATED BY ENGINEERING, WHO PROVIDED THE FOLLOWING FEEDBACK: UNIT WAS RECEIVED IN GOOD WORKING CONDITION. MASSAGE SWITCH WAS IN THE "OFF" POSITION WHILE THE HEAT SWITCH WAS IN THE "ON"POSITION WHEN RECEIVED. THERE ARE 2 SWITCHES LOCATED ON THE UNIT. THE HEAT SWITCH WAS STILL IN THE "ON" POSITION. THE MASSAGE SWITCH WAS SHUT OFF. BOTH SWITCHES WORK AS DESIGNED. THERE WAS NO DEVICE FAILURE NOTICED. THE INSTRUCTION BOOKLET WAS REVIEWED AND IN ADDITION TO OTHER RELEVANT WARNINGS, THE FOLLOWING SPECIFIC WARNINGS ARE INCLUDED: ALWAYS UNPLUG THIS APPLIANCE FROM THE ELECTRICAL OUTLET IMMEDIATELY AFTER USING AND BEFORE CLEANING. ALWAYS CHECK THAT MASSAGER IS IN OFF POSITION, AND SPEED SLIDE IS IN L O W E S T/OFF SETTING BEFORE PLUGGING INTO ELECTRICAL OUTLET.
D
Patient 1
CONSUMER STATE SHE WAS DOZING WHEN SHE WAS USING HER MASSAGER. SHE CLAIMS SHE DIDN'T FEEL THE HEAT. SHE TURNED UNIT OFF, NOT UNPLUGGED AND NOTICED IT SMELLED. WHEN SHE FELT IT , IT WAS EXTREMELY HOT. SHE TAKES PAIN MEDICATION. SHE RECEIVED MEDICAL ATTENTION THE DAY AFTER THE INCIDENT. THE MASSAGER IS A DISCONTINUED PRODUCT.