FDA Adverse Event Injury Summary report: N

DEMEDIOX

MDR report key: 23016282 · Received September 10, 2025

Report

Report Number
3007895168-2025-00002
Event Type
Injury
Date Received
September 10, 2025
Date of Event
July 1, 2025
Report Date
August 5, 2025
Manufacturer
DEMETECH CORPORATION
Product Code
NEW
UDI-DI
10652927784418
PMA / PMN Number
K082097
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

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 SEPTEMBER 4TH, 2025, HCP REPLIED BACK TO THE EMAIL STATING THAT THE THREADS WILL NOT BE EXTRACTED FROM THE PATIENT AND WILL GIVE IT MORE TIME. HCP CONFIRMED THAT THE PATIENT IS NO LONGER EXPERIENCING PAIN. ON SEPTEMBER 5TH, 2025, HCP HAS BEEN INFORMED THAT THE CASE IS NOW CLOSED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2506858 DEMEDIOX ABSORBABLE POLYDIOXANONE SURGICAL SUTURE NEW DEMETECH CORPORATION PX2X45800100A16MTB 10652927784418

Patients

Seq Age Sex Outcome Treatment
1 48 YR Female Other