InjuryISA
HOWMEDIC'S BACK MASSEUR
Received Jan 7, 2000 · Event occurred Dec 25, 1999
Report MW4002674 · MDR key 260214
Device
Generic name
10 Motor Seat Massager
Manufacturer
Howmedics Inc.Model number
3833959Catalog number
NI
Lot number
NI
Product problems
- Labelling, Instructions for Use or Training Problem
- Interference with pacemaker
Patient
NO INFO
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
PT GIVEN MASSAGER FOR CHRISTMAS. SAT IN THE CHAIR AND TURNED ON THE MASSAGER AND HEART BEGAN TO FLUTTER. THE MASSAGER INTERFERED WITH PT'S PACEMAKER. PT FOUND A WARNING AGAINST USE OF THE PRODUCT WITH PACEMAKERS IN THE MANUAL BUT THERE WAS NO WARNING ON THE OUTSIDE OF THE BOX. IF THE WARNING HAD BEEN ON THE BOX, PT'S FAMILY MEMBER WOULD NOT HAVE PURCHASED IT FOR PT.