GHIATAS

Additional Manufacturer Narrative

H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: WEN QIN, JUN GE, ZHIHAO GONG, YUNYUN ZHANG, DAVID M DIBARDINO, ANDREA IMPERATORI, ET. AL.(2022). THE INCIDENCE AND RISK FACTORS OF ACUTE PAIN AFTER PREOPERATIVE NEEDLE LOCALIZATION OF PULMONARY NODULES: A CROSS-SECTIONAL STUDY. TRANSLATIONAL LUNG CANCER RESEARCH, 11(8):1667-1677. DOI: 10.21037/TLCR-22-557. H11: SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED IN AN ARTICLE IN JOURNAL OF ¿TRANSLATIONAL LUNG CANCER RESEARCH¿ TITLED ¿THE INCIDENCE AND RISK FACTORS OF ACUTE PAIN AFTER PREOPERATIVE NEEDLE LOCALIZATION OF PULMONARY NODULES: A CROSS-SECTIONAL STUDY" THAT SOMETIME POST PROCEDURE, TWO HUNDRED AND SIXTY-SIX OF THREE HUNDRED PATIENTS REPORTEDLY EXPERIENCED PAIN DURING DEEP BREATHING AND CHEST MOVEMENT ANALYSIS OF PAIN CHARACTERISTICS. FURTHERMORE, SIXTEEN OF THREE HUNDRED PATIENTS WERE TREATED WITH CYCLOOXYGENASE-2 INHIBITORS WITHOUT PERCEPTIBLE PAIN RELIEF. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

Additional Manufacturer Narrative

H10: WEN QIN, JUN GE, ZHIHAO GONG, YUNYUN ZHANG, DAVID M DIBARDINO, ANDREA IMPERATORI, ET. AL.(2022). THE INCIDENCE AND RISK FACTORS OF ACUTE PAIN AFTER PREOPERATIVE NEEDLE LOCALIZATION OF PULMONARY NODULES: A CROSS-SECTIONAL STUDY. TRANSLATIONAL LUNG CANCER RESEARCH, 11(8):1667-1677. DOI: 10.21037/TLCR-22-557. H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H11: SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED IN AN ARTICLE IN JOURNAL OF ¿TRANSLATIONAL LUNG CANCER RESEARCH¿ TITLED ¿THE INCIDENCE AND RISK FACTORS OF ACUTE PAIN AFTER PREOPERATIVE NEEDLE LOCALIZATION OF PULMONARY NODULES: A CROSS-SECTIONAL STUDY" THAT SOMETIME POST OFF-LABEL USE OF LOCALIZATION HOOK-WIRE, TWO HUNDRED AND SIXTY-SIX OF THREE HUNDRED PATIENTS ALLEGEDLY EXPERIENCED MODERATE TO SEVERE PAIN DURING DEEP BREATHING AND CHEST MOVEMENT ANALYSIS OF PAIN CHARACTERISTICS. REPORTEDLY, SIXTEEN OF THREE HUNDRED PATIENTS HAVE BEEN ADMINISTERED WITH THE CYCLOOXYGENASE-2 INHIBITORS WITHOUT PERCEPTIBLE PAIN RELIEF. THE PATIENTS CURRENT STATUS IS UNKNOWN.