DemeDIOX PX2X45800100A16MTBRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10652927784418), received between Oct 21, 2024 and Sep 10, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 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.

• InjurySep 10, 2025Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  ON AUGUST 5TH, 2025, HCP REPORTED PLACING PDO THREADS ON (B)(6) 2025. ACCORDING TO THE HCP, ON (B)(6) 2025, THE PATIENT EXPERIENCED THREAD MIGRATION AND PROTRUSION APPEARING LIKE A VEIN ON THE FOREHEAD PUSHING ON A NERVE WITH TENDERNESS TO TOUCH. THE HCP STATED THAT THERE WAS A TOTAL PLACEMENT OF 5 THREADS ON ONE SIDE AND 4 THREADS ON THE OTHER. MEDICAL ADVICE WAS REQUESTED BY THE HCP. AN EMAIL WAS SENT TO THE HCP TO GATHER ADDITIONAL INFORMATION. A SECONDARY EMAIL WAS SENT TO THE MEDICAL DIRECTOR FOR MEDICAL ADVICE. ON (B)(6) 2025, MEDICAL ADVICE WAS PROVIDED FROM THE MEDICAL DIRECTOR WHICH WAS FORWARDED TO THE HCP. THE MEDICAL DIRECTOR ADVISED THAT THE PAIN IS PROBABLY FROM SKIN OR MUSCLE AND NOT A NERVE. THE MEDICAL DIRECTOR RECOMMENDED THREAD REMOVAL IF THE PATIENT IS TROUBLED BY APPEARANCE. ON AUGUST 20TH, 2025, AN EMAIL WAS SENT TO THE HCP TO INQUIRE ABOUT THE STATUS OF THE PATIENT AND TO CONFIRM IF ANY THREADS WERE EXTRACTED. ON SEPTEMBER 3RD, A PHONE CALL WAS MADE TO THE HCP TO GATHER INFORMATION ON THE STATUS OF THE PATIENT AND TO CONFIRM IF ANY THREADS WERE EXTRACTED. THE POINT OF CONTACT AT THE HCP WAS NOT AVAILABLE. ANOTHER FOLLOW UP EMAIL WAS SENT TO THE HCP. ON SEPTEM

  Patient problems: Nodule

  MAUDE report 23016282 ↗
• 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 20614221 ↗
• InjuryOct 21, 2024Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  ON SEPTEMBER 6TH, 2024, HCP REPORTED TO THE SALES REPRESENTATIVE THAT A PDO THREAD WAS IMPLANTED ON THE PATIENT'S CHEEK. ACCORDING TO THE HCP, THE PATIENT EXPERIENCED A POP AFTER EATING ON THE LEFT SIDE AND NOW HAS A LITTLE NUMBNESS AND A LITTLE BUMP FORMED IN THE MARIONETTE AREA. HCP ALSO REPORTED THAT THEY TRIED TO REMOVE THE THREAD FROM THE SKIN BY USING A CANNULA AND UNDERMINING THE TISSUE, BUT IT WAS NOT MOVING. ON (B)(6) 2024, THE SALES REPRESENTATIVE HAD ASKED THE HCP FOR PICTURES OF THE PATIENT. ON (B)(6) 2024, HCP PROVIDED THE PICTURES THAT WERE REQUESTED. A REQUEST WAS MADE TO THE MEDICAL DIRECTOR TO OBTAIN MEDICAL ADVICE ON THE CASE. ON (B)(6) 2024, THE MEDICAL DIRECTOR PROVIDED MEDICAL ADVICE WHICH WAS FORWARDED TO THE HCP. ON (B)(6) 2024, FOLLOW UP EMAIL WAS MADE TO THE HCP TO INQUIRE ABOUT THE STATUS OF THE PATIENT. ON OCTOBER 4TH, 2024, FOLLOW UP COMMUNICATION WAS MADE TO THE SALES REPRESENTATIVE TO INQUIRE ABOUT THE STATUS OF THE PATIENT FROM THE HCP. ON (B)(6) 2024, ANOTHER FOLLOW UP EMAIL WAS SENT TO THE HCP TO INQUIRE ABOUT THE STATUS OF THE PATIENT. HCP REPLIED THAT THE PATIENT IS DOING BETTER. ACCORDING TO THE HCP, THEY WERE ABLE TO CUT THE END OF THE THREAD WH

  Patient problems: Nodule; Numbness

  MAUDE report 20500918 ↗