Phasix 1193535Recalls & reported problems
Davol Inc. · Phasix Mesh, 14" x 14" (35 cm x 35 cm), Square · 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 00801741107665), received between May 17, 2024 and May 17, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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
- Tear, Rip or Hole in Device Packaging1
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.
MalfunctionMay 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED, THE OUTER BOX OF THE PHASIX FLAT MESH WAS OPENED AND FOUND THAT THERE WAS A HOLE IN THE INSIDE STERILE PACKAGING (SMALL TEAR IN FOIL POUCH). ANOTHER PHASIX MESH WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED THE OUTER CARTON HAD NOT BEEN OPENED PRIOR AND THERE WAS NO DAMAGE NOTED TO THE OUTER CARTON. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19341809 ↗
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- GalaFORM 3D 100043-04Tepha, Inc. · Surgical Film29 reports
- Phasix 1190400Davol Inc. · surgical film26 reports
- Phasix 1190200Davol Inc. · surgical film22 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.