PROLENE P3DPMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031047525), received between Jan 16, 2019 and Sep 15, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THE PATIENT THAT POST-OP OF A HERNIA REPAIR, THE MESH WAS DEFECTIVE AND IT 'DARN NEAR KILLED ME.' SHE SAID 'IT NEVER FELT RIGHT' FOLLOWING IMPLANT ON (B)(6) 2012. HER SYMPTOMS INCLUDED CONSTIPATION AND PAIN. IN (B)(6) 2019 SHE PRESENTED WITH FEVER AND WAS DIAGNOSED AS SEPTIC. SHE HAD A COLOSTOMY FOR SIX WEEKS AND DAILY ANTIBIOTIC INFUSIONS PRIOR TO SURGERY ON (B)(6) 2019. SHE STATED SHE HAD BEEN IN HOSPITAL FOUR TIMES FOR THIS. IN SURGERY IT WAS DISCOVERED THE PLUG CAME OUT, THE MESH HAD BROKEN UP AND DISPERSED THROUGHOUT HER ABDOMEN. FIVE INCHES OF COLON WERE REMOVED AS WAS THE MESH IMPLANT. SHE STILL HAS AN OPEN WOUND, BUT IT IS HEALING. SHE IS AFEBRILE CURRENTLY. PATIENT HAS GIVEN PERMISSION TO CONTACT HER SURGEON, AND STATED SHE WILL BE CONTACTING AN ATTORNEY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fever; Pain; Sepsis

  MAUDE report 9068526 ↗
• InjuryJan 16, 2019Adverse 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 INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD REMOVAL SURGERY ON (B)(6) 2010 DURING WHICH THE SURGEON NOTED: "ONE MAJOR AND ONE MINOR NERVE TRUNK, ALL OF WHICH WERE TRAPPED IN A MASS OF MESH AND SCAR. THE SURGEON COMMENCED A VERY DIFFICULT AND TEDIOUS DISSECTION AND WAS ABLE TO FULLY EXTRACT UP TOWARD THE PORTION OF THE MATERIAL FROM WITHIN THE RETROPERITONEAL SPACE. THE SURGEON IDENTIFIED A RECURRENCE OR PERSISTENCE OF AN INDIRECT INGUINAL HERNIA SAC IN THE COURSE OF HIS RETROPERITONEAL DISSECTION. THE BASE OF THE RESIDUAL SAC WAS SUTURE LIGATED, THEN WAS AMPUTATED. THE SURGEON MOBILIZED ALL OF THE MESH FROM ITS LATERAL FIXATION POINTS LONG THE INGUINAL LIGAMENT. THE MOST TEDIOUS ASPECT OF THE DISSECTION WAS TRYING TO SEPARATE THE CORD AND ITS CONTENTS FROM THE MESH. THE CORD WAS ACTUALLY CAUGHT BETWEEN THE PLUG AND THE ANTERIOR MESH LEAFLET HAD CREATED A TUNNEL-LIKE EFFECT AROUND THE SPERMATIC CORD." IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, INFLAMMATION, SEXUAL DYSFUNCTION AND NERVE BLOCK TREATMENTS. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Hernia; Pain; Scarring

  MAUDE report 8253312 ↗