D
Patient 1
A CUSTOMER IN (B)(6) REPORTED A (B)(6) PT (MALE) SWALLOWED CYTOLYT SOLUTION WHILE AT THE HOSP (B)(6). WHEN THE ACCIDENT HAPPENED, THE PT WAS TRANSFERRED OT THE ANTIVENIN UNIT DIRECTED BY THE (B)(6). THE PT WAS MONITORED AND TREATED BY (B)(6) FROM THE (B)(6) OF THE HOSP. ONCE THEY RECEIVED THE EXACT COMPOSITION OF THE CYTOLYT AND BY COMPARING THE REPORTED % OF METHANOL WITH THE TOXICOLOGICAL DATE, THE ANTIVENIN UNIT CLOSED THE INCIDENT AND DISCHARGED THE PT FROM THE UNIT. (B)(6) (EU): PER THE CONTENT OF THE CURRENT REVISION OF THE (B)(6) GUIDELINES ON A MEDICAL DEVICE VIGILANCE SYSTEM, THIS WON'T BE CLASSIFIED AS A REPORTABLE EVENT. THE RATIONALE IS AS FOLLOWS: THERE IS NO REPORT OF VIAL OR CAP MFG ISSUES. OUR LABELLING IS IN LINE WITH THE CURRENT EU GUIDELINES AND WE LIST APPROPRIATE WARNINGS IN OUR IFU REGARDING USE OF THE PRODUCT. THIS APPEARS TO BE A CASE OF CLINICAL NEGLIGENCE AND THE ONUS IS ON THE USER TO REPORT VIA THEIR CLINICAL GOVERNANCE PROCEDURES. THIS WOULD BE REGARDED AS A CASE OF ABNORMAL USE OF THE PRODUCT. THE CURRENT (B)(6) GUIDELINES ALSO STATE: 5.1.5.3 CONSIDERATION FOR HANDLING ABNORMAL USE ABNORMAL USE NEEDS NOT BE REPORTED BY THE MFR TO THE NATIONAL COMPETENT AUTHORITY UNDER THE REPORTING PROCEDURES. ABNORMAL USE SHOULD BE HANDLED BY THE HEALTH CARE FACILITY AND APPROPRIATE REGULATORY AUTHORITIES UNDER SPECIFIC APPROPRIATE SCHEMES NOT COVERED BY THIS DOCUMENT. IF MFRS BECOME AWARE OF INSTANCES OF ABNORMAL USE, THEY MAY BRING THIS TO THE ATTENTION OF OTHER APPROPRIATE ORGANIZATIONS AND HEALTHCARE FACILITY PERSONNEL.