DemeDIOX PX2x29800100A16MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10652927721314), received between Jun 11, 2024 and Feb 3, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, HCP REPORTED THAT THE PATIENT EXPERIENCED THREAD PROTRUSION 1 WEEK AFTER INSERTION. AN EMAIL WAS SENT TO THE HCP TO GATHER ADDITIONAL INFORMATION. ON (B)(6) 2025, A PHONE CALL WAS MADE TO THE HCP TO GATHER ADDITIONAL INFORMATION WITH NO RESPONSE. ANOTHER FOLLOW-UP EMAIL WAS SENT TO THE HCP WITH NO RESPONSE. ON (B)(6) 2025, A 2ND FOLLOW-UP EMAIL WAS SENT TO THE HCP. ON (B)(6) 2025, HCP REPLIED TO THE EMAIL PROVIDING THE INFORMATION REQUESTED. HCP REPORTED THAT THE PDO THREADS WERE IMPLANTED ON (B)(6) 2024 AND WERE EXTRACTED ON (B)(6) 2025. ACCORDING TO THE HCP, THE PATIENT'S SKIN HAS HEALED AS PER THE PATIENT'S FOLLOW UP VISIT ON (B)(6) 2025. HCP HAS STATED THE PATIENT HAS ANOTHER AREA OF CONCERN THAT WILL NEED A FOLLOW-UP AND HAS REQUESTED MEDICAL ADVICE FROM THE MEDICAL DIRECTOR. ON (B)(6) 2025, MEDICAL ADVICE WAS PROVIDED BY THE MEDICAL DIRECTOR WHICH WILL BE FORWARDED TO THE HCP. THIS IS AN ONGOING INVESTIGATION. ADDITIONAL INFORMATION WILL BE PROVIDED IF AND WHEN IT IS AVAILABLE.

  Patient problems: Nodule

  MAUDE report 21292327 ↗
• InjuryOct 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  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 CAUS

  Patient problems: Nodule

  MAUDE report 20378221 ↗
• InjuryJul 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THE CUSTOMER REPORTED TO THE SALES REPRESENTATIVE THAT THE PATIENT HAD PDO THREADS COMING OUT FROM THE INSERTION SITE. HCP REQUESTED MEDICAL ADVICE FROM THE MEDICAL DIRECTOR WHICH THEY WERE PROVIDED. THE MEDICAL DIRECTOR SUGGESTED THAT THE THREADS NEED TO BE PULLED OUT AND THE PATIENT NEEDS TO BE PLACED ON ANTIBIOTICS. ON 07/03/2024, ACCORDING TO THE HCP, THREADS NEEDED TO BE PULLED OUT TO BE ABLE TO EXTRACT THE THREADS. HCP STATED THAT THE THREADS WERE EXTRACTED ON (B)(6) 2024. HCP ALSO REPORTED THAT THE PATIENT HAD PDO THREADS IMPLANTED 48 HOURS ((B)(6) 2024) BEFORE THE REMOVAL DATE OF (B)(6) 2024. ON 07/03/2024, HCP STATED THAT THE PATIENT IS FINE AND DOES NOT REQUIRE ANTIBIOTICS.

  Patient problems: Nodule

  MAUDE report 19671182 ↗
• InjuryJun 11, 2024Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  ON JUNE 6TH, 2024, HCP REPORTED TO THE SALES REPRESENTATIVE THAT A PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024 ACCORDING TO THE HCP, PATIENT EXPERIENCED THREADS DISLODGING AT ANCHOR AND THREAD POKING FROM UNDER THE SKIN AT THE ENDPOINT. DURING THE FOLLOW UP, HCP REMOVED THE THREAD AND A NEW THREAD WAS PLACED. ON JUNE 10TH, 2024, HCP REPORTED THAT THE PATIENT IS FINE.

  Patient problems: Nodule

  MAUDE report 19515532 ↗