PROLENE 3DPLRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031005143), received between Oct 12, 2018 and Jun 4, 2026 — classified as 11 injuries.

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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2024 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 25390896 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2007 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22893914 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2015 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2016. IT WAS REPORTED THAT PATIENT EXPERIENCED CHRONIC UMBILICAL MESH INFECTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 22016184 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT REPORTED EXPERIENCING CHRONIC PAIN, DISCOMFORT, PAIN WHEN WALKING AND BENDING, TINGLING AND PULLING SENSATIONS. NO FURTHER INFORMATION COULD BE OBTAINED DUE TO LACK OF CONTACT INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain; Paresthesia

  MAUDE report 22003947 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6)2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT TAKEDOWN OF ENTEROCUTANEOUS FISTULA, SMALL BOWEL RESECTION, REPAIR OF UMBILICAL HERNIA, MESH EXTRICATION AND THREE-LAYER ABDOMINAL WALL CLOSURE ON (B)(6) /2014. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fistula; Hernia

  MAUDE report 21617665 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA SURGERY ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21616697 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 20924557 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20891693 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR ON (B)(6) 2021. IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT EXPERIENCED NAUSEA, VOMITING, AND PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Nausea; Pain; Vomiting

  MAUDE report 20650337 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE, CHRONIC AND ACUTE GROIN PAIN, STRESS AND ANXIETY. OTHER PROCEDURE IS CAPTURED UNDER SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 11870563 ↗
• InjuryOct 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL SURGERY WITH WOUND DEBRIDEMENT AND REPAIR OF AN INCISIONAL HERNIA ON (B)(6) 2016. IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON NOTED ¿AN ABSCESS AND A TRACT THAT LED FROM THE SKIN DOWN TO THE OBVIOUS PALPABLE VISIBLE MESH. THE FISTULA TRACT WAS CORED OUT TO EXPOSE THE FASCIA AND THE MESH WAS EXCISED.¿ IT WAS REPORTED THE WOUND WAS PACKED AND LEFT OPEN TO HEAL BY SECONDARY INTENT. IT WAS REPORTED PATIENT UNDERWENT A LAPAROTOMY WITH REMOVAL OF THE REMAINING INFECTED MESH MATERIAL AND LYSIS OF ADHESIONS ON (B)(6) 2016. IT WAS REPORTED PATIENT PRESENTED TO ER ON (B)(6) 2016 WITH SEVERE PAIN, TACHYCARDIA, AN ENTEROCUTANEOUS FISTULA AND A THICKENED LOOP OF SMALL BOWEL. NO DETAILS ARE PROVIDED REGARDING TREATMENT RECEIVED DURING THIS HOSPITAL STAY OF THREE DAYS. IT WAS REPORTED PATIENT UNDERWENT RECURRENT UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2017; HOWEVER NO DETAILS ARE PROVIDED FROM THIS SURGICAL PROCEDURE. IT WAS REPORTED THE PATIENT CONTINUES TO EXPERIENCE SEVERE PAIN, HOSPITALIZATIONS, HERN

  Patient problems: Hernia; Pain; Unspecified Infection

  MAUDE report 7961260 ↗