Skip to content

Phasix 1190601Recalls & reported problems

Davol Inc. · Phasix Plug and Patch, Medium · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741010613), received between Aug 10, 2021 and Aug 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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

  • Expiration Date Error1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 10, 2021Expiration Date Error; Expiration Date Error

    AS REPORTED, DURING AN OPEN UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 A BARD/DAVOL PHASIX PLUG AND PATCH WAS IMPLANTED. FOLLOWING IMPLANT OF THE MESH IT WAS NOTED THAT THE DEVICE HAD EXPIRED ON (B)(6) 2021. AS REPORTED, THERE HAS BEEN NO MEDICAL OR SURGICAL INTERVENTION FOR THE PATIENT AT THIS TIME. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12302393 ↗

Other Mesh, surgical, absorbable, abdominal hernia devices

All Mesh, surgical, absorbable, abdominal hernia devices →

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