PDS PDP443HRecalls & reported problems
Ethicon, LLC · Antibacterial Clear Monofilament (Polydioxanone), Absorbable Surgical Suture · Class 2 · Implant
Data updated Oct 13, 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 10705031048317), received between Feb 23, 2021 and Feb 23, 2021 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fluid Discharge1
- Inflammation1
- Pocket Erosion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON PERFORMED A BREAST FLAP FROM THE PATIENT¿S BACK AND USED THE SUTURE IN THE DEEPER LAYER. APPROXIMATELY 6 WEEKS POST-OP, THE PATIENT STARTED TO EXPERIENCE SUTURE SPITTING AROUND THE WOUND. THE SURGEON OPINED IT WAS AN INFLAMMATORY REACTION CAUSED BY TRICLOSAN AND THAT INFLAMMATION IS OCCURRING AS WOUND HEALS AND COSMESIS MAY BE AN IMPACTED OUTCOME. PUS AND REMOVAL OF THE SUTURE IS CONTINUALLY REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Fluid Discharge; Inflammation; Pocket Erosion
MAUDE report 11367223 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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