ACTION PATCH
Received Sep 23, 2011 · Event occurred Aug 23, 2011
Report 1721293-2011-00009 · MDR key 2261257
Device
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHEN THE CUSTOMER WAS REMOVING THE ACTION PATCH FROM THE RELEASE LINER CARD THE PATCH PULLED AWAY FROM THE BATTERY. THE PATCH WAS NOT USED.
Additional Manufacturer Narrative
THE REASON THAT PIECES OF THE ELECTRODE ASSEMBLY WERE COMING APART UPON ATTEMPTED REMOVAL IS THAT THE ELECTRODE WILL NOT EASILY RELEASE FROM THE (B)(4) COATED SIDE. THE ELECTRODE WAS PLACED ON THE INCORRECT SIDE OF THE RELEASE LINER. THIS IS A CONSEQUENCE OF AN OPERATOR ERROR DURING MANUFACTURING. THE CLINIC DID NOT USE THE ELECTRODE. "THIS MDR IS BEING REPORTED BECAUSE IN SOME SITUATIONS SUCH AS A MALFUNCTION COULD CONTRIBUTE TO A SERIOUS INJURY IF IT WERE TO RECUR."