DemeDIOX PX2x783090A16MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10652927777489), received between Feb 23, 2024 and Nov 6, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 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 20616290 ↗
• InjuryJun 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  HCP REPORTED THAT THE PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2024. ON 04/22/2024, ACCORDING TO THE HCP, PATIENT CAME IN FOR A FOLLOW-UP 10 DAYS POST PROCEDURE WITH BUNCHING UNDER THE PATIENT'S RIGHT EYE, NEAR THE NOSE. PATIENT DID NOT REPORT ANY PAIN AT THE TIME, BUT FELT SOME PINCHING FROM TIME TO TIME. HCP DECIDED TO LEAVE THE THREAD INSIDE THE PATIENT AND TO MASSAGE IT UNTIL NOT VISIBLE, AS IT WAS NOT AFFECTING THE PATIENT. ON (B)(6) 2024, HCP REPORTED THAT THE PATIENT PRESENTED WITH MORE BUNCHING NEAR THE RIGHT SIDE OF THE NOSE UNDER THE EYE. PATIENT FELT "POKING" AND SOMETIMES PAIN. HCP FELT A THREAD GOING PAST THE PATIENT'S ORBITAL RIM, INTO THE EYE SOCKET. HCP REMOVED THE THREAD. ON 06/12/2024, HCP REPORTED THAT THE PATIENT IS DOING PERFECTLY FINE, AND THAT NO ADDITIONAL FOLLOW-UP IS NEEDED.

  Patient problems: Discomfort; Nodule

  MAUDE report 19563720 ↗
• InjuryJun 18, 2024Break; Material Fragmentation; Patient Device Interaction Problem; Migration; Break; Material Fragmentation; Patient Device Interaction Problem; Migration

  04/22/2024, HCP REPORTED TO THE SALES REPRESENTATIVE THAT THE PATIENT HAD ONE THREAD POKING OUT FROM INSIDE OF THE MOUTH. ACCORDING TO THE HCP, THREAD WAS REMOVED BY THE PATIENT AT HOME. PATIENT REPORTED INTENSE PAIN AT THE DISTAL END OF THE THREAD AND HEARING A "SNAP" SOUND WHEN MOVING. PATIENT ALSO REPORTED FEELING THE THREADS MIGRATE UNDER THE SKIN. AT THE HCP'S CLINIC, PATIENT PRESENTED WITH THREE THREADS POKING FROM UNDER THE SKIN, TWO FROM THE RIGHT SIDE OF THE FACE (NLF AND CHIN), AND ONE RIGHT ON THE PATIENT'S LEFT PYRIFORM AREA. HCP REMOVED TWO THREADS ON THE RIGHT SIDE. HCP ATTEMPTED TO REMOVE THE THIRD THREAD ON THE PATIENT'S LEFT SIDE, BUT WAS UNSUCCESSFUL. 06/12/2024, HCP REPORTED THAT THE PATIENT IS FINE AND NO ADDITIONAL FOLLOW-UP WAS NEEDED.

  Patient problems: Discomfort; Nodule

  MAUDE report 19561695 ↗
• InjuryMay 9, 2024Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  ON (B)(6) 2024, THE PATIENT REPORTED THAT THEY HAD PDO THREADS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, ACCORDING TO THE HCP, PATIENT EXPERIENCED PAIN WITH THE THREAD POKING UNDER THE SKIN AT THE ENDPOINT IN THE MIDDLE OF THE NECK. DURING THE FOLLOW-UP, PATIENT WAS INJECTED WITH HYALURONIC ACID BY THE HCP TO SOFTEN THE THREAD. ACCORDING TO THE HCP, PATIENT PRESENTED NO CHANGES TWO WEEKS LATER. PATIENT EXPERIENCED ANOTHER PDO THREAD MIGRATED FROM THE JAWLINE INTO THE CHIN. HCP EXTRACTED THE THREAD AND ATTEMPTED TO REMOVE ANOTHER THREAD AT THE THYROID CARTILAGE ASPECT BUT WAS UNSUCCESSFUL. PATIENT WAS INJECTED WITH HYALURONIC ACID BY THE HCP AGAIN TO SOFTEN THE THREAD. ON (B)(6) 2024, HCP WAS INFORMED BY THE PATIENT THAT THE THREAD HAD EXTRUDED OUT. ON (B)(6) 2024, THE HCP CONFIRMED THAT THE PATIENT IS CURRENTLY IN GOOD CONDITION.

  Patient problems: Discomfort; Nodule

  MAUDE report 19281936 ↗
• InjuryFeb 23, 2024Break; Material Fragmentation; Patient Device Interaction Problem; Migration; Break; Material Fragmentation; Patient Device Interaction Problem; Migration

  (B)(6) 2024, HCP REPORTED THAT A PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE HCP, PATIENT EXPERIENCED THREAD POKING UNDER THE SKIN AT THE ENDPOINT. (B)(6) 2024, PATIENT VISITED HCP FOR FOLLOW-UP AS TWO THREADS WERE BROKEN AND MIGRATED TO THE LIP. TWO PIECES OF THE BROKEN THREADS WERE REMOVED. (B)(6) 2024, PATIENT HAD ANOTHER FOLLOW UP WITH THE HCP WHERE TWO ADDITIONAL BROKEN THREADS WERE REPORTED. ONE THREAD MIGRATED TO THE CHIN AND WAS NOT REMOVED WHILE ONE BROKEN THREAD WAS REMOVED FROM THE LIP AREA. POST CARE TREATMENT RECOMMENDATIONS INCLUDED NOT TO DO ACTIVE SPORT AND FACE MOVEMENTS. MEDICAL ADVICE FROM THE MEDICAL DIRECTOR WAS OFFERED BUT THE HCP DECLINED. (B)(6) 2024, AFTER CONDUCTING A FOLLOW UP CONTACT WITH THE PRACTICE MANAGER, IT WAS CONFIRMED THAT THE PATIENT IS IN GOOD CONDITION.

  Patient problems: Nodule

  MAUDE report 18768824 ↗
• InjuryFeb 23, 2024Break; Material Fragmentation; Patient Device Interaction Problem; Break; Material Fragmentation; Patient Device Interaction Problem

  (B)(6) 2024, HCP REPORTED THAT THE PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE HCP, THE PATIENT EXPERIENCED THREAD POKING UNDER THE SKIN AT THE ENDPOINT. ON THE FOLLOW UP APPOINTMENT ON (B)(6) 2024, HCP REPORTED HAVING REMOVED ONE PIECE OF BROKEN PDO THREADS LOCATED INSIDE ON THE CHEEK OF THE PATIENT'S FACE. HCP RECOMMENDED NOT TO DO ACTIVE SPORT AND FACE MOVEMENT FOR POST CARE TREATMENT. MEDICAL ADVICE FROM THE MEDICAL DIRECTOR WAS OFFERED BUT THE HCP DECLINED. FEBRUARY 7TH, 2024, AFTER CONDUCTING A FOLLOW UP CONTACT WITH THE PRACTICE MANAGER, IT WAS CONFIRMED THAT THE PATIENT IS IN GOOD CONDITION.

  Patient problems: Nodule

  MAUDE report 18768744 ↗
• InjuryFeb 23, 2024Break; Material Fragmentation; Patient Device Interaction Problem; Break; Material Fragmentation; Patient Device Interaction Problem

  JANUARY 25TH 2024, HCP REPORTED THAT THE PATIENT HAD PDO THREADS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE HCP, THE PATIENT EXPERIENCED THREAD POKING UNDER THE SKIN AT THE ENDPOINT. ON THE FOLLOW UP APPOINTMENT ON (B)(6) 2023, HCP REPORTED HAVING REMOVED ONE PIECE OF BROKEN PDO THREADS LOCATED ON THE RIGHT SIDE OF THE PATIENT'S FACE. MEDICAL ADVICE FROM THE MEDICAL DIRECTOR WAS OFFERED BUT THE HCP DECLINED. FEBRUARY 7TH, 2024, AFTER CONDUCTING A FOLLOW UP CONTACT WITH THE PRACTICE MANAGER, IT WAS CONFIRMED THAT THE PATIENT IS IN GOOD CONDITION.

  Patient problems: Nodule

  MAUDE report 18767938 ↗