NEOSPORIN SCAR SOLUTION
Received May 23, 2007 · Event occurred May 14, 2007
Report 2246407-2007-00003 · MDR key 855339
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
26 YR
- Irregular Pulse
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
A FEMALE CONSUMER USED 1 SHEET OF NEOSPORIN SCAR SOLUTION SILICONE SCAR SHEET (SILICONE) ONCE IN 2007. FOR A SCAR ON HER LEFT ARM. AT 7:30 PM THE SAME DAY, SHE HAD RAPID HEART BEAT OF 160 (UNIT UNSPECIFIED) AND A METALLIC TASTE IN HER MOUTH. SHE WENT TO THE EMERGENCY ROOM AND RECEIVED AN UNSPECIFIED INTRAVENOUS WITH AN UNSPECIFIED MEDICATION TO SLOW HER HEART RATE. HER "HEART ENZYMES WERE OK" AND BLOOD WORK CAME OUT FINE. AFTER SIX HOURS OBSERVATION, "THEY FOUND NOTHING WRONG" SHE WAS RELEASED. AT THE TIME OF REPORTING ON TWO DAYS LATER, THE EVENTS RESOLVED.
Additional Manufacturer Narrative
THE PROD WAS NOT RETURNED FOR FAILURE ANALYSIS/LAB TESTING. IT CANNOT BE RULED OUT THAT THE PROD MAY HAVE POSSIBLY CAUSED THE EVENT.