Phasix 1192540Recalls & reported problems
Davol Inc. · Phasix Mesh, 10" x 16" (25 cm x 40 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 00801741107658), received between Dec 19, 2023 and Dec 19, 2023 — 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.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Patient Device Interaction Problem1
Patient problems
- Bacterial Infection1
- Necrosis1
- Wound Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem
PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA SAC WAS IDENTIFIED AND EXCISED. A VENTRIO MESH (DEVICE #1) WAS POSITIONED INTO THE PERITONEAL CAVITY AND TACKED TO THE ANTERIOR ABDOMINAL CAVITY." (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL INFECTION, CELLULITIS AND INFECTED MESH THEREBY UNDERWENT EXPLORATORY LAPAROTOMY WITH THE REMOVAL OF MESH (DEVICE #1). PER OPERATIVE NOTES, "INCISION WAS CARRIED DOWN TO THE LEVEL OF THE MESH (DEVICE #1) AND NOTED THAT THERE WAS A COPIOUS AMOUNT OF FLUID AROUND THE MESH AND SUCTIONED OUT. LYSIS OF ADHESIONS WAS PERFORMED AND THERE WAS NOTED SOME ADHERENT SMALL BOWEL INTRABDOMINAL CONTENT. ONCE, THIS WAS DONE THE MESH (DEVICE #1) WAS REMOVED." (B)(6) -2018 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESHES (DEVICE #2 & DEVICE #3). PER OPERATIVE NOTES, ¿HERNIA SAC WAS RESECTED AND A PHASIX MESH (DEVICE #2) WAS TRIMMED, PLACED AND SUTURED TO THE RECTUS SHEATH. ANOTHER PHASIX MESH (DEVICE
Patient problems: Bacterial Infection; Necrosis; Wound Dehiscence
MAUDE report 18354051 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.