DemeDIOX PX4x4086025A16SRecalls & reported problems
Demetech Corporation · Absorbable Polydioxanone Surgical Suture · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10652927668251), received between Nov 29, 2024 and Nov 29, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Discomfort1
- Nodule1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 29, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON JUNE 11TH, 2024, THE PATIENT CONTACTED NOVATHREADS DIRECTLY OVER EMAIL EXPLAINING HER CONCERNS ABOUT THREADS IMPLANTED ON HER OVER A YEAR AGO. PATIENT WAS CLAIMING THAT THE THREADS PUT HER IN THE ICU AS WELL AS OTHER PATIENTS IN THE OFFICE (SHE WAS A FORMER EMPLOYEE AT (B)(6)). SHE CLAIMS TO HAVE DOCUMENTATION THAT SHOWS THAT THE THREADS ARE NOT SAFE. SHE STATES THAT IF NOTHING IS DONE, SHE WILL FILE A LAWSUIT DUE TO THE DAMAGES AND HARM IT CAUSED HER. SHE CLAIMS TO TAKE THIS TO THE NEWS IF NOVATHREADS DOES NOT REPLY WITH A SOLUTION. ON JUNE 11TH, 2024, NOVATHREADS CONTACTED THE PATIENT OVER EMAIL REQUESTING THE PROVIDER CONTACT INFORMATION TO INITIATE AN INVESTIGATION. PATIENT REPLIED WITH CONTACT INFORMATION AND PROVIDED PICTURES AND VIDEOS OF HER PROCEDURE. ACCORDING TO THE PATIENT, SHE WOKE UP THE FOLLOWING DAY AFTER THE PROCEDURE WITH HER FACE AS DEMONSTRATED IN THE PICTURES PROVIDED. PICTURES SHOW SWELLING/BUMPS ON THE FACE AND BRUISING UNDER THE CHIN (NECK AREA). PATIENT STATED THAT SHE WENT STRAIGHT TO THE CUSTOMER'S OFFICE. THE NURSE PRACTITIONER WOULD NOT SEE HER AND HAD HER SISTER (NURSE INJECTOR/RN) SEE THE PATIENT. THE NURSE PRACTITIONER TOLD THE NURSE INJECTOR TO T
Patient problems: Discomfort; Nodule; Swelling/ Edema
MAUDE report 20812311 ↗
Other Suture, Surgical, Absorbable, Polydioxanone devices
- STRATAFIX SXPP1A405Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE617 reports
- STRATAFIX SXPP1A400Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE485 reports
- STRATAFIX SXPP1A401Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE446 reports
- STRATAFIX SXPP1A301Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE443 reports
- STRATAFIX SXPP2B405Ethicon, LLC · Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A406Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE339 reports
- STRATAFIX SXPP1A404Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
- STRATAFIX SXPP1B420Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death229 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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