Parietex PCO3728FXRecalls & reported problems
Sofradim Production · Optimized Composite Mesh,Polyester with Absorbable Collagen Film · Class 2 · Implant
All models of Parietex (73)
Data updated Oct 16, 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 10884521179660), received between Nov 14, 2019 and Nov 14, 2019 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Abdominal Distention1
- Abscess1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Ascites1
- Bacterial Infection1
- Chest Pain1
- Depression1
- Diaphoresis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A DIAPHRAGMATIC HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PHYSICAL PAIN, MENTAL ANGUISH, DEPRESSION, DISABILITY, PSYCHOLOGICAL STRESS, LOSS OF ENJOYMENT OF LIFE, AND HERNIA RECURRENCE. POST-OPERATIVE TREATMENT INCLUDED ANTERIOR VENTRAL HERNIA REPAIR, ADDITIONAL SURGERIES, HOSPITALIZATION, HERNIA REPAIR WITH NEW IMPLANTS, REPAIR THE ANTERIOR CHEST WALL AND ANTERIOR ABDOMINAL WALL DEFECT WITH MESH, RECONSTRUCT THE ANTERIOR INFERIOR ASPECT OF DIAPHRAGM WITH MESH, AND REMOVAL OF THE MESH.
Patient problems: Abdominal Distention; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Bacterial Infection; Chest Pain; Depression; Diaphoresis; Distress; Emotional Changes; Erythema; Fistula; Fluid Discharge; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hernia; Impaired Healing; Inflammation; Injury; Pain; Pleural Effusion; Purulent Discharge; Tachycardia; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 9320063 ↗
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- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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