Additional Manufacturer Narrative · 1
SINCE THE DEVICE HAS NOT BEEN RETURNED TO NOPA, IT COULD NOT BE INVESTIGATED. OUR U.S. DISTRIBUTOR, FACILITY, HAS REQUESTED THE RETURN OF THE INSTRUMENT. IF IT IS DETERMINED, THAT THE DEVICE INVOLVED IN THE EVENT IS A NOPA PRODUCT, A COMPLAINT INVESTIGATION WILL BE PERFORMED AND DOCUMENTED AND THE COMPLAINT INVESTIGATION REPORT SUBMITTED. AT THAT TIME, NOPA WILL ALSO COMPLETE THE BASELINE REPORT, FORM FDA 3417, BECAUSE THIS WOULD BE THE FIRST TIME THAT ONE OF OUR MOUTH GAGS HAD BEEN INVOLVED IN A REPORTABLE EVENT. NOPA MANUFACTURES CUSTOM MOUTH GAGS, INCLUDING THE MOUTH GAG MULT CHILD, EXCLUSIVELY FOR FACILILTY, SINCE 06/21/2004. TO DATE THERE HAVE BEEN NO COMPLAINTS. THE DESCRIPTION OF THE 'PROBLEM' SEEMS TO INDICATE THAT THERE WAS NO ISSUE WITH THE SAFETY AND EFFECTIVENESS OF THE DEVICE BUT THAT THE SUDDEN REMOVAL OF THE DEVICE BY THE PT RELEASED THE SMALL PURE SILICONE TUBE (APPROX. 2 1/2 CM) THAT COVERS THE VALVE TO PROTECT THE SENSITIVE TISSUE OF THE MOUTH. WITH A VIEW TOWARDS POSSIBLE CORRECTIVE ACTIONS, CONSIDERATION MUST BE GIVEN TO THE FACT THAT THESE TUBES MUST REMAIN REMOVABLE FOR EFFECTIVE DEVICE PROCESSING.