PerFix 0112950Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741016653), received between Oct 24, 2017 and Sep 30, 2026 — classified as 37 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (32 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 38 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2008: Patient was diagnosed with indirect and direct right inguinal hernia thereby underwent open repair with the implant of PerFix Plug (right - Device 1, left - Device 2). Per op notes, ¿On right groin, there was a direct inguinal hernia consisting of a direct hernia sac which was dissected away from the cord structures. Mild indirect hernia was noted. A medium sized Marlex Mesh was placed in the direct defect and sutured. A small mesh plug was placed in indirect defect and sutured to the shelving edge of inguinal ligament and a precut preshaped keyhole patch was placed on the floor of the inguinal canal.¿ (b)(6) 2013 ¿ Patient had right lower quadrant pain.(b)(6) 2013 ¿ Patient had pain thereby underwent ilioinguinal nerve block.

  Patient problems: Pain

  MAUDE report 50944372 ↗
• InjuryMar 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OPERATIVE NOTES, ¿A TRANSVERSE INCISION WAS MADE IN THE RIGHT LOWER QUADRANT. THE HERNIA SAC WAS DISSECTED OUT. A PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE RIGHT INGUINAL FLOOR AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 2). PER OPERATIVE NOTES, ¿A TRANSVERSE ELLIPTICAL INCISION WAS MADE SHARPLY THROUGH PREVIOUS SKIN SCAR. THE HERNIA SAC WAS DISSECTED OUT. A SMALL PERFIX PLUG (DEVICE 2) WAS PLACED INTO THE RIGHT INGUINAL FLOOR AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH AND EXPLANT OF PERFIX PLUG (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿A TRANSVERSE INCISION WAS MADE EXCISING THE PREVIOUS SKIN SCAR. THE HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED BOTH PERFIX PLUG (DEVICE 1 AND DEVICE 2) WAS DISSECTED OUT. A SYNTHETIC MESH WAS PLACED INTO THE RIGHT ING

  Patient problems: Hernia

  MAUDE report 24482111 ↗
• InjuryDec 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, ¿A SMALL HERNIA DEFECT WAS NOTED, AND THE HERNIA WAS EXCISED. A PERFIX PLUG (DEVICE 1) WAS PLACED IN THE HERNIA DEFECT AND SECURED WITH SUTURES. ¿ ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿ADHESIONS TO PREVIOUS MIDLINE INCISION AND PRIOR MESH (DEVICE 1) WERE LYSED. THE HERNIA WAS IDENTIFIED AND REDUCED. A SYNTHETIC MESH WAS PLACE AND TACKED.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE 2). PER OP NOTES, ¿THE HERNIA SAC WAS LOCATED ABOVE THE FASCIA AND DISSECTED FROM SURROUNDING TISSUES. THE PREVIOUS PLACED MESH (DEVICE 1) WAS NOTED. A VENTRALEX ST (DEVICE 2) WAS PLACED AND SUTURED.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RUQ ABDOMINAL PAIN AND RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF PERFIX PLUG (DEVICE 1) AND VENTRALEX ST (DEVICE 2). PER OP NOTES, ¿MINIMA

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Seroma

  MAUDE report 23897534 ↗
• InjuryNov 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUGS (DEVICE 1 AND 2). PER OP NOTES, ¿TWO DIRECT DEFECTS WERE NOTED IN RIGHT INGUINAL REGION WHICH WAS REPAIRED WITH PERFIX PLUGS (DEVICE 1 AND 2), TACKED AND SUTURED¿. ON (B)(6) 2016: PATIENT WAS DIAGNOSED WITH RIGHT GROIN PAIN AND LEG PAIN, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 3). PER OP NOTES, ¿IN THE RIGHT INGUINAL REGION, DUE TO EXTENSIVE SCAR DISSECTION WAS CARRIED OUT WHERE THE SPERMATIC CORD IS FOUND ADHERENT TO THE PERFIX PLUGS (DEVICE 1 AND 2). BOTH ILIOINGUINAL NERVE AND GENITOFEMORAL NERVE WAS EXCISED. A PERFIX PLUG (DEVICE 3) WAS PLACED INTO THE DILATED INTERNAL RING AND SUTURED.¿

  Patient problems: Adhesion(s); Nerve Damage; Pain

  MAUDE report 23474574 ↗
• InjuryJul 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿A DIRECT HERNIA SAC IN THE RIGHT INGUINAL REGION WAS IDENTIFIED AND REDUCED. A SMALL PERFIX PLUG (DEVICE #1) WAS PLACED USING PROLENE SUTURES. A DIRECT HERNIA SAC IN THE LEFT INGUINAL REGION WAS IDENTIFIED AND REDUCED. A PERFIX PLUG (DEVICE #2) WAS PLACED USING PROLENE SUTURES. ¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX (DEVICE #3 & #4). PER OPERATIVE NOTES, ¿A DIRECT HERNIA DEFECT WAS IDENTIFIED IN THE RIGHT INGUINAL REGION SUPERIOR TO PUBIC TUBERCLE AND REDUCED. THE ADHESIONS AND SCAR TISSUE OF PRIOR MESH WAS TAKEN DOWN. A 3DMAX (DEVICE #3) WAS PLACED AND TACKED. A LARGE DIRECT HERNIA DEFECT WAS IDENTIFIED IN THE LEFT INGUINAL REGION AND REDUCED. THE PRIOR MESH WAS IDENTIFIED AND ADHERENT TO CORD STRUCTURES WERE TAKEN DOWN. A 3DMAX WAS PLACED AND TACKED. ¿

  Patient problems: Adhesion(s); Hernia; Scar Tissue

  MAUDE report 22370498 ↗
• InjuryJan 4, 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) 2020 AND (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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 13149832 ↗
• InjuryDec 2, 2021Defective Device; 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 ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 12915400 ↗
• InjurySep 21, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL PERFIX PLUG ON (B)(6) 2019. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED SERIOUS PERSONAL INJURIES AND DAMAGES AS A RESULT OF THE DEFECTIVE DEVICE. ATTORNEY ALLEGES THAT FROM THE DATE OF IMPLANT OF HERNIA MESH, THE PATIENT HAS EXPERIENCED EXTREME PAIN, TROUBLE URINATING, INFECTIONS AND OTHER ONGOING PROBLEMS AS A DIRECT RESULT OF THE HERNIA MESH. ATTORNEY ALSO ALLEGES THAT THE DEVICE WAS DEFECTIVE. ADDENDUM PER LEGAL CLAIM: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR LEFT INGUINAL HERNIA REPAIR WITH MESH ON (B)(6) 2019. ATTORNEY ALLEGES THE REPAIR CONSISTED OF THE FOLLOWING PRODUCT: BARD/DAVOL PERFIX PLUG. IT IS ALLEGED THAT SHORTLY AFTER RECOVERING FROM THE SURGERY, THE PATIENT BEGAN EXPERIENCING SEVERE PAIN, NUMBNESS, TROUBLE URINATING AND ONGOING INFECTIONS IN LEFT INGUINAL/GROIN AREA. IT IS ALLEGED THAT ON (B)(6) 2020, THE PATIENT WAS EXAMINED BY PHYSICIANS DUE TO THE SEVERE PAIN AND WAS DIAGNOSED WITH ILIOINGUINAL NERVE ENTRAPMENT. IT IS ALLEGED THAT AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE PERFIX PLUG, IT HAS CAUSED THE PATIENT SEVERE PAIN AND PERMANENT BODILY INJURIES, NUMBNESS IN THE LEFT

  Patient problems: Dysuria; Nerve Damage; Pain; Unspecified Infection

  MAUDE report 12509830 ↗
• InjuryMay 30, 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, PERFIX PLUG AND VENTRALIGHT ST ON (B)(6) 2012 AND/OR (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX MESH AND 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 11905847 ↗
• InjuryMar 31, 2021Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2016. 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: Hernia; Insufficient Information; Nerve Damage; Pain

  MAUDE report 11599191 ↗
• InjuryNov 8, 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 THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST. 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: Abdominal Pain; Adhesion(s); Disability; Hernia; Injury; Pain; Scar Tissue

  MAUDE report 10806729 ↗
• InjurySep 23, 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) 2012. 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); Disability; Injury; Pain; Scar Tissue

  MAUDE report 10572024 ↗
• InjuryJul 24, 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) 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; Unspecified Infection

  MAUDE report 10319378 ↗
• InjuryMar 3, 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) 2010. 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 9779268 ↗
• InjuryDec 12, 2019Defective 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) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. AS REPORTED, THE 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."

  Patient problems: Disability; Hernia; Injury; Pain

  MAUDE report 9459938 ↗
• InjurySep 27, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

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

  Patient problems: Adhesion(s); Hernia; Injury; Scar Tissue

  MAUDE report 9131066 ↗
• InjuryAug 14, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2015, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. AS REPORTED, THE 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."

  Patient problems: Adhesion(s); Disability; Injury; Nerve Damage; Pain; Scar Tissue

  MAUDE report 8895178 ↗
• InjuryJul 17, 2019Defective 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) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL PERFIX PLUG. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain; Scar Tissue

  MAUDE report 8799537 ↗
• InjuryJul 2, 2019Defective 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) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. AS REPORTED, THE 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."

  Patient problems: Disability; Injury; Nerve Damage; Pain; Scar Tissue

  MAUDE report 8754971 ↗
• InjuryJul 1, 2019Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2012, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #1) AND AN UNSPECIFIED BARD/DAVOL VENTRALEX ST. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG (DEVICE #1). AS REPORTED, THE 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."

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 8750327 ↗
• InjuryJun 7, 2019Defective 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 (DEVICE #1) AND A VENTRALEX ST (DEVICE #2) ON (B)(6) 2016 OR (B)(6) 2016. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL PERFIX PLUG (DEVICE #1) AND VENTRALEX ST (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Bacterial Infection; Injury; Sepsis

  MAUDE report 8680096 ↗
• InjuryMay 22, 2019Defective 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) 2017. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL PERFIX PLUG. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Nerve Damage; Pain

  MAUDE report 8633422 ↗
• InjuryMay 14, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT IN 2007 THE PATIENT UNDERWENT A RIGHT INGUINAL HERNIA REPAIR WITH PLACEMENT OF A PERFIX PLUG (DEVICE 1). AS REPORTED IN 2008, THE PATIENT UNDERWENT AN UMBILICAL AND LEFT INGUINAL HERNIA REPAIR WITH PLACEMENT OF ONE PERFIX PLUG (DEVICE 2) IN THE UMBILICAL SPACE AND TWO PERFIX PLUGS (DEVICE 3 AND 4) IN THE LEFT INGUINAL SPACE. IT IS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION WITH DRAINAGE FROM THE UMBILICAL HERNIA REPAIR SITE (DEVICE 2). AS REPORTED IN 2013 THE PATIENT UNDERWENT EXPLANT OF THE UMBILICAL MESH (DEVICE 2) DUE TO THE CHRONIC INFECTION WHICH LED TO A FISTULA FORMATION INTO THE COLON. DURING THIS PROCEDURE A BOWEL RESECTION WAS PERFORMED TO REMOVE THE FISTULA. AS REPORTED THE PATHOLOGY REPORTS NOTES INFLAMMATION IN THE AREA OF THE EXPLANTED MESH (DEVICE 2). IT IS REPORTED THAT THE AREA HAS HEALED WELL WITH NO SIGNS OF INFECTION OR RECURRENT HERNIA. THE CONTACT REPORTS THAT THE PATIENT IS EXPERIENCING PAIN IN THE BILATERAL INGUINAL REPAIR SITES (DEVICE 1, 3, 4) IN WHICH HE HAS SCHEDULED A VISIT WITH A SURGEON TO ASSESS THE PAIN.

  Patient problems: Disability; Injury; Pain

  MAUDE report 8607154 ↗
• InjuryApr 22, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2015. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL PERFIX PLUG. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury; Pain

  MAUDE report 8537879 ↗
• InjuryMar 21, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2012. IT IS ALLEGED THAT THE PATIENT HAD UNSPECIFIED INJURIES AND CONSULTATIONS WITH MEDICAL PROVIDERS. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PERFIX PLUG. AS REPORTED, THE 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."

  Patient problems: Disability; Injury; Pain

  MAUDE report 8441351 ↗