Description of Event or Problem · 0
ON (B)(6) 2024, THE HCP REPORTED THAT PDO THREADS WERE IMPLANTED IN TWO PATIENTS AND BOTH PATIENTS EXPERIENCED BUCKLING. ON (B)(6) 2024, MEDICAL ADVICE WAS PROVIDED TO THE HCP BY THE MEDICAL DIRECTOR. ON OCTOBER 28TH, THE SALES REPRESENTATIVE WAS CONTACTED TO GATHER INFORMATION AND STATUS OF THE PATIENTS WHICH THEY WERE UNABLE TO PROVIDE. ON NOVEMBER 01, 2024, HCP WAS CONTACTED AND PROVIDED INFORMATION REGARDING THE TWO PATIENTS INVOLVED. ACCORDING TO THE HCP, THE FIRST PATIENT IS NO LONGER IN CONTACT WITH THE HCP AND THE SECOND PATIENT HAD THREADS REMOVED AND A SCHEDULED FOLLOW-UP APPOINTMENT. HCP WAS NOT COOPERATING WITH ANSWERING FURTHER QUESTIONS. ON NOVEMBER 12TH, 2024, A FOLLOW-UP EMAIL WAS SENT TO THE SALES REPRESENTATIVE TO ASSIST IN GATHERING ADDITIONAL INFORMATION. ON NOVEMBER 19TH, THE SALES REPRESENTATIVE MANAGER WAS CONTACTED TO ASSIST IN GETTING ADDITIONAL INFORMATION FOR THE CASE. ON DECEMBER 5TH, A PHONE CALL WAS MADE TO THE SALES REPRESENTATIVE WITH NO ANSWER. ON DECEMBER 6TH, THE SALES REPRESENTATIVE RETURNED THE CALL AND INFORMED THAT THE INFORMATION WAS RELAYED TO THE HCP TO GATHER THE ADDITIONAL INFORMATION. ACCORDING TO THE SALES REPRESENTATIVE, THE HCP DID NOT FOLLOW-UP WITH PROVIDING ADDITIONAL INFORMATION. THE CASE HAS BEEN CONFIRMED TO BE CLOSED AS THE HCP IS NOT COOPERATING WITH PROVIDING THE NECESSARY INFORMATION.