Skip to content

Phasix 1190602Recalls & reported problems

Davol Inc. · Phasix Plug and Patch, Large · 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 00801741010620), received between Mar 20, 2022 and Mar 20, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (1 report).

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

  • Defective Device1
  • Patient Device Interaction Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryMar 20, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PHASIX PLUG AND PATCH, LG, 1.5 X 1.9 ON (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PHASIX PLUG AND PATCH. ATTORNEY ALLEGES THAT THE PATIENT HAD UNSPECIFIED INJURY DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

    Patient problems: Insufficient Information

    MAUDE report 13829706 ↗

Other surgical film devices

All surgical film devices →

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