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ULTRAPRO COMFORT PLUG UPLUG553Recalls & reported problems

Johnson & Johnson International Inc. · Partially Absorbable Hernia Repair Device · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031228474), received between Jun 3, 2021 and Jun 3, 2021 — classified as 2 injuries.

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 Problem2

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Hernia2
  • Pain2
  • Discomfort1
  • Nausea1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2016 AND ULTRAPRO COMFORT PLUG WAS IMPLANTED. IT WAS REPORTED THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. IT WAS REPORTED THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Hernia; Nausea; Pain

    MAUDE report 11935749 ↗
  • InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2016 AND ULTRAPRO COMFORT PLUG WAS IMPLANTED. IT WAS REPORTED THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. IT WAS REPORTED THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hernia; Pain

    MAUDE report 11935747 ↗

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.