PDS PDP740DRecalls & reported problems
Ethicon, LLC · Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture · Class 2 · Implant
- 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 10705031218826), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Erythema1
- Inflammation1
- Purulent Discharge1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN TRAUMA PROCEDURE ON AN (B)(6) 2024 AND SUTURE WAS USED ON MUSCLE FASCIA. POST-OP, 4 DAYS AFTER THE SURGERY, THE WOUND WAS FOUND WITH ERYTHEMA AND INFLAMMATION WITH INFECTION. THE SUTURE WAS REMOVED FROM THE PATIENT AND THE WOUND WAS RE-SUTURED. THIS EVENT PROLONGED PATIENT'S HOSPITALIZATION TIME. THE PATIENT IS CURRENTLY STABLE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Erythema; Inflammation; Purulent Discharge; Unspecified Infection
MAUDE report 18932133 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.