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ULTRAPRO COMFORT PLUG UPLUG406Recalls & reported problems

Johnson & Johnson International Inc. · Partially Absorbable Hernia Repair Device · 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 10705031228436), received between Nov 26, 2020 and Nov 26, 2020 — 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

  • Erythema1
  • Fluid Discharge1
  • Inflammation1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIOPLASTY ON (B)(6) 2020 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ERYTHEMA, INFLAMMATION, HEAT AND PAIN ON THE INCISION ON (B)(6) 2020 AFTER USING THE PRODUCT IN THE SURGERY OF INGUINAL HERNIOPLASTY. IT WAS ALSO REPORTED THAT ON (B)(6) 2020, THERE WAS WOUND SECRETION ON THE INCISION EVEN THOUGH DRESS CHANGING WAS GIVEN PREVIOUSLY. IT WAS ALSO REPORTED ON (B)(6) 2020, THE MESH WAS REMOVED BY A SECOND SURGERY. THE INCISION HEALED AFTER SEVERAL TIMES OF DRESS CHANGING.

    Patient problems: Erythema; Fluid Discharge; Inflammation; Pain

    MAUDE report 10910343 ↗

Other Mesh, surgical, polymeric devices

All Mesh, surgical, polymeric devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.