Ovitex® PRS R20143-1620PRecalls & reported problems
Aroa Biosurgery Limited · Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 09421905067706), received between Aug 7, 2024 and Aug 7, 2024 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT SELF REPORTED ONGOING LEFT BREAST INFECTION AFTER BILATERAL IMPLANT BASED BREAST RECONSTRUCTION WITH OVITEX PRS PERMANENT. IT WAS REPORTED THAT AN INFECTION DEVELOPED AFTER THE ORIGINAL SURGERY WHICH RESULTED IN THE REMOVAL OF THE IMPLANT AND OVITEX PRS DEVICE. THE PATIENT REPORTED ONGOING INFECTION IN THE LEFT BREAST AND "ISSUES IN THE LEFT IMPLANT" EVEN AFTER THE REMOVAL OF THESE ORIGINAL DEVICES. THE PATIENT ALSO EXPERIENCED REDNESS AND HEAT ON THE AFFECTED BREAST. THEY ALSO NOTED A LACK OF ENERGY, SPORADIC FEVERS, AND GENERAL MALAISE. NO RESOLUTION WAS NOTED IN THE REPORT.
Patient problems: Bacterial Infection
MAUDE report 19930628 ↗
Other Mesh, Surgical devices
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- Peri-Guard PC1016NSynovis Life Technologies, Inc. · Mesh, surgical1 recall1 report
- SurgiMend® 606-200-020Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-005-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-008Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-200-016Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-021Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-206-007Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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