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Phasix 1190616Recalls & reported problems

Davol Inc. · Phasix Mesh, 2.4" x 6.3" (6 cm x 16 cm), Rectangle · 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 00801741107528), received between Jun 14, 2021 and Jun 14, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

  • Patient-Device Incompatibility1

Patient problems

  • Abdominal Pain1
  • Abscess1
  • Nausea1
  • Post Operative Wound Infection1
  • Vomiting1

Recent adverse event reports

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

  • InjuryJun 14, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED SUBCUTANEOUS ABSCESS AND SURGICAL SITE INFECTION POST-IMPLANT OF PHASIX MESH. ON (B)(6) 2021 - THE SUBJECT PATIENT UNDERWENT AN OPEN EXPLORATORY LAPAROTOMY PROCEDURE AT THE UMBILICAL SITE. A BARD/DAVOL PHASIX MESH WAS TRIMMED AND PLACED IN ONLAY FASHION. THE MESH WAS FIXATED USING SUTURE. FASCIAL CLOSURE WAS ACHIEVED WITH NON-BARD/DAVOL SUTURE, IN A CONTINUOUS RUNNING STITCH TECHNIQUE. IT WAS REPORTED THAT PROPHYLACTIC ANTIBIOTIC (METRONIDAZOLE, CEFTRIAXONE) WERE ADMINISTERED TO THE PATIENT PERI-OPERATIVELY. ON (B)(6) 2021 - THE SUBJECT PATIENT WAS DIAGNOSED WITH A SSI (SURGICAL SITE INFECTION) OF THE SUPERFICIAL SKIN LAYER AND SUBCUTANEOUS ABSCESS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED ON ORAL ANTIBIOTICS. ON (B)(6) 2021- THE SUBJECT PATIENT WAS DISCHARGED HOME TO CONTINUE THE ORAL ANTIBIOTICS. AS REPORTED, THE REPORTED ADVERSE EVENT OF HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE OUTCOME OF THE ADVERSE EVENT IS RECOVERING/RESOLVING AND THE SEVERITY IS REPORTED TO BE MODERATE.

    Patient problems: Abdominal Pain; Abscess; Nausea; Post Operative Wound Infection; Vomiting

    MAUDE report 11991621 ↗

Other surgical film devices

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