DUOLOCK TAIL CLSR CURVED TAN

Additional Manufacturer Narrative

INITIAL EMDR IS BEING RE-SUBMITTED PER REQUEST OF FDA ON 02-APR-2021. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: TWO CASES ASSOCIATED WITH THIS COMPLAINT. A SEPARATE FDA FORM 3500A HAS BEEN COMPLETED FOR THE UNKNOWN NUMBER OF AFFECTED PRODUCTS WITH MULTIPLE POSSIBLE LOTS NUMBERS ASSOCIATED WITH THIS COMPLAINT. REPORTED TO THE FDA ON MARCH 25, 2016 ON 06-JUN-2016, THE FOLLOWING CORRECTION WAS IDENTIFIED: DUE TO THE SITE OF MANUFACTURE UPDATE, THE INITIAL MDR, MFR REPORT 1000317571-2016-00031 IS BEING REPLACED WITH MFR REPORT # 9618003-2016-00028. THE MFR REPORT # FIELD, MANUFACTURER HAVE BEEN UPDATED TO REFLECT THIS CHANGE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON JUNE 22, 2016 ON (B)(6) 2016, THE FOLLOWING CORRECTION WAS IDENTIFIED: ADDITIONAL INFORMATION RECEIVED INDICATES THE PREVIOUSLY REPORTED LOT NUMBER 5E03205 IS INCORRECT. THE LOT NUMBER FOR THIS REPORTED EVENT COULD NOT BE OBTAINED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON NOVEMBER 2, 2016. (B)(4).

Description of Event or Problem

IT WAS REPORTED BY THE END USER THAT THE TAIL CLIPS DIG AND IRRITATE HER FLESH IN THE AREA OF THE ABDOMEN WHERE THE CLIP RESTS/DIGS IN. IT WAS ALSO REPORTED THAT THIS HAS OCCURRED WITH OTHER SIMILAR PRODUCTS FOR YEARS.

Additional Manufacturer Narrative

CORRECTED DATA: DUE TO THE SITE OF MANUFACTURE UPDATE, THE INITIAL MDR, MFR REPORT 1000317571-2016-00031 IS BEING REPLACED WITH MFR REPORT # 9618003-2016-00028. THE MFR REPORT # FIELD, D3 AND G9 HAVE BEEN UPDATED TO REFLECT THIS CHANGE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON JUNE 22, 2016. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITES: 9618003.