Description of Event or Problem · 0
ON (B)(6) 2024, HCP REPORTED A PDO THREAD LIFT WITH FOUR THREADS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE HCP, ELEVEN DAYS LATER (B)(6) 2024), THE PATIENT EXPERIENCED SWELLING IN THE RIGHT MUCOSA. HCP PRESCRIBED AUGMENTIN AND PREDNISONE TO THE PATIENT. HCP STATED AFTER 1.5 MONTHS, THE THREADS WERE PALPABLE ON THE PATIENT'S CHEEK AND MUCOSA, WITH NODULES ON THE MUCOSA AND A 0.5 CM NODULE ON THE RIGHT SIDE OF THE PATIENT'S FACE. ON (B)(6) 2024, HCP PROVIDED PICTURES OF BEFORE AND AFTER THE PROCEDURE. HCP STATED THAT SEVEN WEEKS AFTER THE PROCEDURE, THE LESION APPEARED AND WAS ALREADY DOING MUCH BETTER. BUCCAL MUCOSA WAS SWOLLEN AND BUMPY ALONG THE COURSE OF THE THREAD. ACCORDING TO THE HCP, SWELLING INSIDE OF THE PATIENT'S CHEEKS AND SKIN NEVER REALLY WENT AWAY. HCP REQUESTED MEDICAL ADVICE FROM THE MEDICAL DIRECTOR. ON (B)(6) 2024, THE MEDICAL DIRECTOR WAS SENT THE INFORMATION PERTAINING TO THIS CASE TO PROVIDE MEDICAL ADVICE. ON (B)(6) 2024, THE MEDICAL DIRECTOR PROVIDED MEDICAL ADVICE TO THE HCP WHICH THE MEDICAL DIRECTOR STATED: "APPEARS TO BE A GRANULOMA - IF THEY FELT THE THREAD INSIDE THE BUCCAL MUCOSA IT WAS PROBABLY TOO DEEP / TOO CLOSE TO THE ORAL CAVITY AND MAY HAVE CAUSED THE INFECTION/GRANULOMA. I WOULD HAVE THEM TREAT THIS LIKE ANY OTHER GRANULOMA BASED ON THEIR MEDICAL DIRECTOR'S ASSESSMENT/JUDGMENT. IN MY PRACTICE, I TREAT GRANULOMAS WITH ORAL ANTIBIOTICS AND INTRALESIONAL 5-FU AND DILUTED TRIAMCINOLONE (K-5) AND REPEAT AFTER 4-6 WEEKS AS NEEDED." THE HCP REQUESTED TO HAVE SOMEONE CALL HER AS THERE HAVE BEEN A FEW DEVELOPMENTS WITH THE PATIENT. ACCORDING TO THE HCP, THERE IS A PUSS AT STENSON'S DUCT, AND THE HCP HAS THE PATIENT ON CLINDAMYCIN. ON (B)(6) 2024, THE HCP'S CONTACT INFORMATION WAS PROVIDED TO THE MEDICAL DIRECTOR TO CALL THE HCP DIRECTLY. THE MEDICAL DIRECTOR STATED THAT HE LEFT A VOICEMAIL WITH THE HCP. ON (B)(6) 2024, FOLLOW UP COMMUNICATION WAS MADE TO THE HCP, WHICH THEY REPLIED THAT THEY DID SPEAK WITH THE MEDICAL DIRECTOR AND THE PATIENT WAS REFUNDED. PATIENT HAS NOT FOLLOWED UP WITH THE HCP. ON (B)(6) 2024, ANOTHER FOLLOW-UP WAS MADE TO THE HCP TO INQUIRE ABOUT THE STATUS OF THE PATIENT. ON (B)(6) 2024, HCP STATED THAT THE PATIENT HAS NOT REPLIED TO ANY FURTHER COMMUNICATION. THE CASE IS CLOSED AS THE PATIENT HAS NOT REPLIED TO ANY COMMUNICATIONS FROM THE CUSTOMER AND THE CUSTOMER IS UNABLE TO PROVIDE THE STATUS OF THE PATIENT.