PerFix 0112960Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 00801741016660), received between Feb 27, 2014 and Feb 5, 2026 — classified as 3 deaths, 102 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (99 reports).

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 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2016: PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA, RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (RIGHT - DEVICE 1, LEFT - DEVICE 2). PER OP NOTES, ¿WEAKNESS IN THE FLOOR OF THE INGUINAL CANAL NOTED. THE RECURRENT HERNIA WAS IDENTIFIED WHERE THE MESH WAS DETACHED SUPERIORLY. THE LOOSE SYNTHETIC MESH WAS RESECTED. A PERFIX PLUG (DEVICE 1) WAS PLACED INTO DEFECT AND ONLAY PORTION OF MESH WAS PLACED OVER THE OLD SYNTHETIC MESH USING SUTURE. ON LEFT SIDE, HERNIA SAC WAS DISSECTED. THE FLOOR WAS REPAIRED BY PLACING A MEDIUM SIZED PERFIX PLUG (DEVICE 2) THROUGH THE INTERNAL RING AND KEYHOLE PORTION OF MESH WAS PLACED OVER THE FLOOR SECURED USING SUTURES.¿ ON (B)(6) 2018: PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, TWO RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH THE REMOVAL OF MESH (DEVICE 1, 2) AND IMPLANT OF 3DMAX MESHES (DEVICE 3, 4). PER OP NOTES, ¿PATIENT HAD BILATERAL RECURRENT HERNIAS. AN OLD MESH PLUG (DEVICE 1) ON RIGHT SIDE. SIGNIFICANT AMOUNT OF SCAR TISSUE AND ADHESION OF PERITONEAL TO RIGHT SIDED MESH. THE RECURRENT HERNIA WAS REDUCED, AND

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24266560 ↗
• InjuryJan 8, 2026Device Appears to Trigger Rejection; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2012- PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 1 AND 2). PER OP NOTES, ¿TWO HERNIA DEFECTS WERE IDENTIFIED IN THE RIGHT INGUINAL REGION AND WAS DISSECTED. A MEDIUM SIZED PERFIX PLUGS (DEVICE 1 AND 2) WAS PLACED AND SUTURED¿. (B)(6) 2018- PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA WITH PAIN, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF PERFIX PLUGS (DEVICE 1 AND 2) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿A LARGE BUNDLE OF SCAR TISSUE AND THE PERFIX PLUGS (DEVICE 1 AND 2) FOUND PROTRUDING OUT OF PATIENT¿S INTERNAL RING AND SCARRED THE EXTERNAL RING. THE ILIOINGUINAL NERVE WAS THEN IDENTIFIED AND FOUND TO BE SCARRED INTO THE MESH BALL. THE SCAR TISSUE ALONG WITH THE PERFIX PLUGS (DEVICE 1 AND 2) WERE EXCISED AND THE PLUGS WERE FOUND ADHERENT TO THE CORD. THE DIRECT SPACE WAS NOW IDENTIFIED AND A SYNTHETIC MESH WAS PLACED AND SUTURED¿.

  Patient problems: Hernia; Nerve Damage; Pain; Scar Tissue

  MAUDE report 24001500 ↗
• InjuryNov 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2001, PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OPERATION NOTES, "AN INCISION WAS MADE IN THE LEFT GROIN, A PERFIX PLUG (DEVICE 1) WAS PLACED USING PROLENE SUTURES." ON (B)(6) 2002, PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 2) AND UMBILICAL HERNIA REPAIR WITH MARLEX MESH. PER OPERATION NOTES, "AN INCISION WAS MADE IN THE LEFT GROIN, THE PREVIOUS MESH PLUG (DEVICE 1) WAS FOUND AND PLACED AN ANOTHER PERFIX PLUG (DEVICE 2). ATTENTION TO THE UMBILICUS, THE UMBILICUS WAS REPAIRED WITH UNKNOWN MARLEX MESH." ON (B)(6) 2002, PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 3). PER OPERATION NOTES, "AN INCISION WAS MADE IN THE OLD WOUND, AND DISSECTION WAS CARRIED OUT. A BARD FLAT MESH (DEVICE 3) WAS PLACED." (NOTE: THE PREVIOUSLY PLACED PERFIX PLUG (DEVICE 2) WAS NOT SEEN DURING THIS PROCEDURE). ON (B)(6) 2002, PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT REPAIR THE IMPLANT OF

  Patient problems: Hernia

  MAUDE report 23542259 ↗
• InjuryJul 31, 2025Migration; Migration

  PER INFORMATION PROVIDED: (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #1). PER OP NOTES, ¿A LARGE INDIRECT HERNIA SAC WAS IDENTIFIED AND REDUCED. A SMALL CORD LIPOMA WAS NOTED AND EXCISED. A LARGE PERFIX PLUG (DEVICE #1) WAS PLACED WITH ONLAY PATCH USING PROLENE SUTURES.¿ (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA WITH PAIN AND LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #2 & #3). PER OP NOTES, ¿ON RIGHT INGUINAL REGION THE PRIOR MESH (DEVICE #1) WAS ADHERENT TO EXTERNAL OBLIQUE WAS TAKEN DOWN AND OPENED. AN INDIRECT HERNIA DEFECT WAS IDENTIFIED AND REDUCED. A PERFIX PLUG (DEVICE #2) WAS PLACED AND SUTURED. THE PREVIOUS MESH (DEVICE #1) WAS INTACT AND SEWED BACK AGAIN WITH SUTURES. ON THE LEFT INGUINAL REGION AN INDIRECT SAC WAS IDENTIFIED AND REDUCED. A PERFIX PLUG (DEVICE #3) WAS PLACED AND SUTURED.¿ (B)(6) 2010 ¿ PATIENT HAD A RIGHT LOWER QUADRANT AND GROIN PAIN. (B)(6) 2019 ¿ PATIENT HAD A CHRONIC RIGHT GROIN PAIN. (B)(6) 2020 ¿ IT WAS ALLEGED THAT THE PATIENT HAD RIGHT GROIN PAIN AND MODERATE INFECTION SUGGESTED WITH PAIN

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22676280 ↗
• DeathMay 14, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCISIONAL UMBILICAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF NON-BARD/BD PROCEED MESH. PER OP NOTES, ¿THE UMBILICAL DEFECT WAS CLOSED THEN SYNTHETIC MESH WAS PLACED, SECURED USING SUTURES AND TACKS.¿ (B)(6) 2011 - PATIENT UNDERWENT WOUND EXPLORATION AND REMOVAL OF INFECTED MESH. PER OP NOTES, ¿THE PURULENT FRAGMENTED MESH THAT BECAME LOOSE IN SUBCUTANEOUS TISSUES WAS REMOVED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH PANTALOON RIGHT DIRECT AND INDIRECT INGUINAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUG (DEVICE #1 & #2). PER OP NOTES, ¿THE PANTALOON RIGHT DIRECT AND INDIRECT INGUINAL HERNIAS WAS REPAIRED USING TWO PERFIX PLUG (DEVICE #1 & DEVICE #2). AN OVERLAY PATCH AS WELL AS PLACED AND SECURED USING SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH CHRONIC NON-HEALING WOUND AND INFECTED MESH THEREBY UNDERWENT REPAIR WITH MESH EXPLANT. PER OP NOTES, ¿THE PURULENT MATERIAL FROM CHRONIC GROIN ABSCESS CAVITY WAS ASPIRATED. THE 2 MESH PLUGS WITH COVERING MESH (DEVICE #1 & #2) ADHERENT TO SURROUNDING STRUCTURE WERE REMOVED.¿

  Patient problems: Abscess; Adhesion(s); Impaired Healing; Unspecified Infection

  MAUDE report 22018646 ↗
• InjuryMar 28, 2025Defective Device; Patient-Device Incompatibility; Material Deformation; Migration; Defective Device; Patient-Device Incompatibility; Material Deformation; Migration

  ATTORNEY ALLEGES PER THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX PLUG. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT.¿ IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Fistula; Hernia; Insufficient Information; Nerve Damage; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 21718131 ↗
• InjuryMay 16, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT.¿ IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 16937605 ↗
• DeathApr 26, 2023Defective Device; Material Deformation; Patient Device Interaction Problem; Migration; Defective Device; Material Deformation; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL PERFIX PLUG AND VENTRALIGHT ST ON (B)(6)2013 AND/OR (B)(6)2014 AND/OR (B)(6)2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Pain

  MAUDE report 16813407 ↗
• InjurySep 12, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain; Scar Tissue

  MAUDE report 15401273 ↗
• InjuryJun 8, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL PERFIX PLUGS ON (B)(6) 2004 AND (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2021. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 14629692 ↗
• InjuryMay 24, 2022Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2012. AS REPORTED THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX PLUG. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Nerve Damage; Pain; Scar Tissue

  MAUDE report 14484326 ↗
• InjuryApr 11, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 14075342 ↗
• InjuryMar 28, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 13934347 ↗
• InjuryFeb 14, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2007. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX PLUG. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 13524511 ↗
• InjuryNov 15, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 12808969 ↗
• InjuryJul 6, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX PLUG. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 12121405 ↗
• InjuryJun 28, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL 3DMAX MESH AND PERFIX PLUG (X2). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG (X1) WHICH WAS IMPLANTED ON (B)(6) 2005. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 12073428 ↗
• InjuryMay 11, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX PLUG. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Pain

  MAUDE report 11805914 ↗
• InjuryMar 26, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 11573431 ↗
• InjuryFeb 3, 2021Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PERFIX PLUG. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2007, (B)(6) 2013 AND (B)(6) 2019. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Hernia; Injury; Pain

  MAUDE report 11271927 ↗
• InjuryDec 31, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 11103107 ↗
• InjuryDec 25, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL PERFIX PLUG (X3) ON (B)(6) 2009 AND (B)(6) 2016 (X2). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Hernia; Injury; Pain; Scar Tissue

  MAUDE report 11073536 ↗
• InjuryDec 18, 2020Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Hernia; Injury; Pain

  MAUDE report 11036278 ↗
• InjurySep 22, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2006. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury; Nerve Damage

  MAUDE report 10565167 ↗
• InjurySep 18, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Hematoma; Injury; Unspecified Infection

  MAUDE report 10554908 ↗