SPROTTE®

Additional Manufacturer Narrative

EVENT TOOK PLACE IN FRANCE. DUE TO A MISSING FDA CODE, THE IMDRF-E21 CODE PROCEDURAL COMPLICATIONS, AN FDA CODE 2388 "INADEQUATE PAIN RELIEF" ADAPTED TO THE PATIENT SITUATION WAS SELECTED. IT WOULD BE ADVANTAGEOUS IF THE FDA WERE TO INITIATE THE ASSIGNMENT OF THE CORRESPONDING FDA CODE FOR IMDRF - E, E21 PROCEDURAL COMPLICATIONS. THIS PRODUCT ANALYSIS WAS CARRIED OUT ON THE BASIS OF ALL THE INFORMATION PROVIDED AND THE INTERNAL REVIEW AT PAJUNK. BASED ON ANALYSIS, RISK ASSESSMENT, RISK PROFILE AND CLINICAL MONITORING THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

Description of Event or Problem

IRN# (B)(4). INCIDENT OCCURRED IN FRANCE: ORIGINAL TEXT: RACHIANESTHÉSIE POUR CURE D'HÉMORROÏDES CHEZ UN PATIENT OBÈSE. UTILISATION D'UNE AIGUILLE, PONCTION FACILE MAIS PAS DE REFLUX DE LIQUIDE CÉPHALO RACHIDIEN. 3 ESSAIS SUPPLÉMENTAIRES INFRUCTUEUX, LE DERNIER ESSAI AVEC DES DOULEURS IRRADIANT LA FESSE DROITE PROBABLEMENT LIÉES AU FROTTEMENT AVEC UNE RACINE. ARRÊT DES ESSAIS DE PONCTION, TEST DE L'AIGUILLE AVEC DU SÉRUM. CONSTAT D'IMPOSSIBILITÉ D'INJECTION (ET DONC DE REFLUX DU LIQUIDE CÉPHALO-RACHIDIEN CAR SEMBLE BOUCHÉ. CONSÉQUENCES: 4 PONCTIONS DANS LA DURE MÈRE, RISQUES DE CÉPHALÉES POST DURALES, HÉMATOMES PÉRI-MÉDULLAIRE, LÉSIONS NEUROLOGIQUES ET PORTE D'ENTRÉE INFECTIEUSE. ACTIONS ENTREPRISES : ARRÊT COMPLET DES ESSAIS POUR UNE RACHIANESTHÉSIE. UNE ANESTHÉSIE GÉNÉRALE A ÉTÉ FAITE. SUIVI POST OPÉRATOIRE : RAS TRANSLATION: SPINAL ANESTHESIA FOR HEMORRHOID TREATMENT IN AN OBESE PATIENT. USE OF A NEEDLE, EASY PUNCTURE BUT NO REFLUX OF CEREBROSPINAL FLUID. 3 FURTHER UNSUCCESSFUL ATTEMPTS, THE LAST ONE WITH PAIN RADIATING TO THE RIGHT BUTTOCK, PROBABLY DUE TO FRICTION WITH A ROOT. PUNCTURE ATTEMPTS STOPPED; NEEDLE TESTED WITH SERUM. NO INJECTION POSSIBLE (AND THEREFORE NO CEREBROSPINAL FLUID REFLUX, AS IT SEEMS BLOCKED). CONSEQUENCES: 4 PUNCTURES INTO THE DURA MATER, RISK OF POST-DURAL HEADACHES, PERI-MEDULLARY HAEMATOMAS, NEUROLOGICAL LESIONS AND INFECTIOUS PORTAL OF ENTRY. ACTION TAKEN: COMPLETE CESSATION OF SPINAL ANAESTHESIA TRIALS. GENERAL ANAESTHESIA WAS USED. POSTOPERATIVE FOLLOW-UP: ALL CLEAR.