DemeDIOX PX2X46800100A16BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10652927697879), received between Nov 5, 2024 and Dec 16, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A HEALTHCARE PROVIDER (HCP) REPORTED THAT A PATIENT PRESENTED WITH PALPABLE PDO BARB THREADS BENEATH THE SKIN ALONG THE RIGHT MANDIBLE. THE THREADS WERE NOT EXTERNALLY VISIBLE. THE HCP NOTED A LOCALIZED ELEVATION AT THE SITE WITH NO ERYTHEMA, DRAINAGE, OR TENDERNESS OBSERVED. THE HCP ATTEMPTED TO ACCESS THE AREA USING AN 18G NEEDLE TO REMOVE OR TRIM THE THREADS; HOWEVER, THE REMOVAL ATTEMPT WAS UNSUCCESSFUL. THE HCP REQUESTED MEDICAL GUIDANCE. ON (B)(6) 2025, THE MEDICAL DIRECTOR PROVIDED INSTRUCTIONS TO UTILIZE THE THREADMATE TOOL AND SUPPLIED THREAD-REMOVAL INSTRUCTIONAL MATERIALS. ON (B)(6) 2025, A FOLLOW-UP WAS CONDUCTED TO OBTAIN UPDATED INFORMATION REGARDING THE PATIENT AND TO DETERMINE WHETHER THREAD REMOVAL WAS SUCCESSFUL. THE HCP REPORTED THAT THEY WERE UNABLE TO VISUALIZE THE THREADS AND THAT REMOVAL ATTEMPTS REMAINED UNSUCCESSFUL. THE HCP REQUESTED ADDITIONAL MEDICAL GUIDANCE. THE MEDICAL DIRECTOR SUBSEQUENTLY OFFERED TO EVALUATE THE PATIENT IN PERSON THROUGH A CONSULTATION. AT THE TIME OF THIS REPORT, NO INFECTION, DRAINAGE, OR ADVERSE SYSTEMIC SYMPTOMS HAVE BEEN REPORTED. PATIENT OUTCOME REMAINS UNCHANGED, AND MEDICAL EVALUATION IS PENDING. UPDATE WILL

  Patient problems: Nodule

  MAUDE report 23817668 ↗
• InjuryDec 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  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 NO

  Patient problems: Nodule

  MAUDE report 20925424 ↗
• InjuryNov 5, 2024Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  ON OCTOBER 25TH, 2024, HCP REPORTED TO THE SALES REPRESENTATIVE THAT PDO THREADS WERE IMPLANTED ON EACH SIDE HIGH ON THE PATIENT'S NECK. ACCORDING TO THE HCP, THE PATIENT EXPERIENCED PUNCHING AND COILING IN THE MIDDLE OF THE NECK AND APPEARED THAT A THREAD WAS A LITTLE OUTPOUCHING ALONG THE ANTERIOR PLATYSMAL BAND ON ONE SIDE. HCP STATED THAT THEY TRIED TO PULL BACK THE THREAD THAT WAS PROTRUDING AND IT APPEARED TO GO IN FLAT. HCP ALSO STATED THAT THEY CUT THE THREADS AND WIPED OFF THE PATIENT. HCP MENTIONED THAT WHEN THE PATIENT SAT UP, THE PATIENT WAS DEMONSTRATING OUTPOUCHING AS WELL AS THE COIL. ACCORDING TO THE HCP, HCP TRIED TO RETRACT THE END OF THE THREAD BUT WAS UNABLE TO FIND THE THREAD WITH FORCEPS. HCP REPORTED THAT THE PATIENT WAS TREATED WITH BBL HERO RIGHT AWAY AND USED THREE DIFFERENT FILLERS TO ACHIEVE DIFFERENT DEPTH AND HEAT UP THE TISSUE. COIL WAS STILL PRESENT AFTER USING THE BBL. HCP HAS REQUESTED MEDICAL ADVICE AND HAS A FOLLOW-UP SCHEDULED WITH THE PATIENT. ON OCTOBER 28TH, 2024, THE MEDICAL DIRECTOR PROVIDED MEDICAL ADVICE TO THE HCP. THE MEDICAL DIRECTOR RECOMMENDED BBL OR ANY OTHER LASER / HEAT MODALITY WILL NOT HELP THIS SITUATION. THE MEDICAL DIRECTOR A

  Patient problems: Nodule

  MAUDE report 20614205 ↗