Phasix 1190400Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741077692), received between Apr 10, 2018 and Mar 31, 2026 — classified as 22 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (10 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Device Appears to Trigger Rejection

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 1). PER OP NOTES, "THE HERNIA AT THE PREVIOUS INCISION SITE WAS NOTED. A PREPERITONEAL FAT STUCK WITHIN THE HERNIA WAS REDUCED. A ROUND VENTRALIGHT ST USING ECHO PS (DEVICE 1) WAS PLACED INTO ABDOMINAL CAVITY AND PULLED UP TOWARDS THE ANTERIOR ABDOMINAL WALL TO HERNIA USING SUTURES." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, "RECURRENT HERNIA AND EVENTRATION OF THE PREVIOUS MESH (DEVICE 1) WAS NOTED. ADHESIOLYSIS WAS PERFORMED. MYOCUTANEOUS FLAPS WERE RAISED TO BRING THE RECTUS MUSCLES BACK TOWARDS THE MIDLINE TO RESTORE ABDOMINAL WALL FUNCTION AND REDUCE PAIN OF THE MESH PROTRUDING THROUGH AND PUTTING PRESSURE ON THE ANTERIOR ABDOMINAL WALL. A PIECE OF PHASIX MESH (DEVICE 2) WAS PLACED AS AN ONLAY AND SECURED DOWN TO FASCIA USING SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIG

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

  MAUDE report 24744016 ↗
• MalfunctionMar 20, 2026Use of Device Problem

  AS REPORTED, DURING AN EXPLORATORY LAPAROSCOPIC SMALL BOWEL RESECTION AND VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2026 THE PATIENT WAS IMPLANTED WITH A PHASIX MESH THAT HAD A LABELED EXPIRATION DATE OF 28-FEB-2026. THERE WAS NO PATIENT INJURY, NO CHANGE IN MEDICAL TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE. AS REPORTED, THE MESH REMAINS IMPLANTED IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24653834 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2008: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿A MODERATE SIZED HERNIA WAS NOTED. THE MESH DID SEEM TO BE PULLED TO THE RIGHT, AND THE HERNIA DEFECT WAS TO THE LEFT. THE HERNIA SAC WAS EXCISED. A LARGE VENTRALEX MESH (DEVICE 1) WAS PLACED INTO DEFECT AND SUTURED.¿ (B)(6) 200: PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, ¿THE BOWEL WAS DISSECTED FROM THE INTERNAL PORTION OF SAC, MESH AND ABDOMINAL WALL. SEVERAL MESH (DEVICE 1) PARTICLES WERE REMOVED. THE BOWEL WAS TAKEN DOWN FROM ADHESION. A VENTRALEX MESH (DEVICE 2) WAS PLACED AND SEWN INTO STRONG FASCIA.¿ (B)(6)2016: PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 2) AND IMPLANT OF XENMATRIX AB (DEVICE 3). PER OP NOTES, ¿THE PATIENT HAD HAD NUMEROUS HERNIAS REPAIRED IN THE PELVIS SECONDARY TO C-SECTIONS. SMALL DILATED LOOPS OF BOWEL WERE NOTED. A CHRONICALLY INCARCERATED UMBILICAL HERNIA WAS

  Patient problems: Adhesion(s); Bacterial Infection; Hernia; Impaired Healing

  MAUDE report 24569845 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED INFRAUMBILICAL AND PERIUMBILICAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST (DEVICE 1). PER OP NOTES, ¿A LARGE INCARCERATED INCISIONAL HERNIA AT THE LEVEL OF UMBILICUS. THE HERNIA WAS REDUCED. THE INCARCERATED OMENTUM WAS REDUCED. A VENTRALIGHT ST (DEVICE 1) WAS PLACED AND TACKED.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE 1) AND IMPLANT OF VENTRALIGHT ST (DEVICE 2), VENTRIO ST (DEVICE 3). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND ADHERENT TO ABDOMINAL WALL. THE CONTENTS OF HERNIA SAC WERE REDUCED. THE FAILED PRIOR MESH (DEVICE 1) WAS RESECTED. THE HERNIA SAC ALSO EXCISED. A VENTRALIGHT ST (DEVICE 2) WAS PLACED AND INTRA-ABDOMINAL CAVITY AND SECURED WITH SUTURES. THE VENTRIO ST (DEVICE 3) WAS PLACED AND TACKED.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH FASCIAL DEHISCENCE WITH SMALL BOWEL EVISCERATION THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE 2), VENTRIO ST (DEVICE 3) AND IMPLANT OF PHASIX

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23788638 ↗
• InjurySep 30, 2025Material Deformation; Material Deformation

  AS REPORTED, PATIENT EXPERIENCED CHRONIC DRAINING SINUS AND INFECTION ABOUT 5 MONTHS AGO. AFTER ADDRESSING THE INFECTION AND SINUS ISSUE, THE SURGEON IMPLANTED A PHASIX MESH AS AN ONLAY. PER INFORMATION REPORTED, THE PATIENT HAD RECURRENCE OF THE SINUS DRAIN AND INFECTION. THE SURGEON OPERATED AND FOUND THAT THE PHASIX MESH OVER THE MIDLINE SEEMED TO HAVE ENCAPSULATED, WAS NOT INCORPORATED, AND WAS WRINKLED AT THE AREA. THE UNINCORPORATED PHASIX MESH WAS REMOVED AND THE ABDOMEN WAS CLOSED PRIMARILY.

  Patient problems: Unspecified Infection

  MAUDE report 23180045 ↗
• InjuryJul 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC IN MID ABDOMEN WAS IDENTIFIED AND DISSECTED DOWN TO EDGES OF FASCIA. A VENTRIO ST MESH (DEVICE #1) WAS PLACED OVER THE DEFECT AND SUTURED AND STAPLED.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRIO ST MESH (DEVICE #1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿DENSE ADHESIONS WERE REMOVED. THE MESH (DEVICE #1) APPEARED TO BE CONTRACTED, INDURATED. THE MESH (DEVICE #1) WAS REMOVED. THE RECURRENT INCISIONAL HERNIA WAS IDENTIFIED AND SAC WAS DISSECTED AND SYNTHETIC MESH WAS PLACED AND SUTURED.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿IN LOWER MIDLINE, DENSE SCAR TISSUE WITH ADHESIONS AROUND HERNIA SAC WAS EXCISED. THE RECURRENT HERNIA WAS REPAIRED WITH SUTURES. ¿ (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF S

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

  MAUDE report 22563106 ↗
• InjuryJul 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #1) AND COMPOSIX MESH (DEVICE #2). PER OP NOTES, "A BARD FLAT MESH (DEVICE #1) AND COMPOSIX MESH (DEVICE #2) WAS PLACED AND SUTURED." (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH INFECTED MESH THEREBY UNDERWENT EXPLANT OF BARD FLAT MESH (DEVICE #1) AND COMPOSIX MESH (DEVICE #2). PER OP NOTES, "MULTIPLE ADHESIONS WERE LYSED. THE BARD FLAT MESH (DEVICE #1) AND COMPOSIX MESH (DEVICE #2) WERE EXCISED." (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH WOUND EVISCERATION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "A SYNTHETIC MESH WAS PLACED AND SUTURED." (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "A SYNTHETIC MESH WAS PLACED AND SUTURED." (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH LARGE VENTRAL HERNIA WITH FISTULA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF SYNTHETIC MESHES AND IMPLANT OF BIOLOGICAL MESH. PER OP NOTES, "THE MESH ADHERENT TO THE BOWEL WAS TAKEN DOWN. THE PREVIOUSLY PLACED SYNTHETIC MESHES WERE EX

  Patient problems: Seroma

  MAUDE report 22370509 ↗
• InjuryMay 2, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  INITIAL EMDR - PER INFORMATION PROVIDED: ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH. PER OPERATIVE NOTES, ¿TISSUE PROTRUDING THROUGH THE HERNIA DEFECT, WHICH WERE DISSECTED OFF THE SURROUNDING ADHESIONS AND PUSHED BACK INTO THE PERITONEAL CAVITY. A VENTRALEX ST MESH (DEVICE #1) WAS PLACED IN THE RETROPERITONEAL POSITION USING SUTURE.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE CONTENTS OF THE HERNIA WERE IDENTIFIED. ADHESIOLYSIS WAS PERFORMED. THE OLD VENTRALEX ST MESH (DEVICE #1) WAS DISSECTED FREE FROM THE ABDOMINAL WALL. THE RECURRENT HERNIA WAS INFERIOR TO THE MESH AND SAC WAS EXCISED. MYOFASCIAL ADVANCEMENT FLAP WAS PERFORMED. THE PHASIX MESH (DEVICE #2) WAS THEN ATTACHED LATERALLY TO THE EDGE OF THE EXTERNAL OBLIQUE USING SUTURE.¿ ON (B)(6) 2022 - PATIENT HAD HERNIA RECURRENCE, ADHESION, INFLAMMATION AND PAIN THEREBY UNDERWENT MESH REVISION. (NOTE: THERE IS NO INFORMATION WAS PROVIDED IN MEDICAL RECORD).

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

  MAUDE report 21949251 ↗
• InjurySep 12, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SUPRAUMBILICAL ABDOMINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC CONTAINING PREPERITONEAL FAT DUE TO OBESITY WAS EXCISED. THE UMBILICUS HAD A SMALL HERNIA THAT WAS CONNECTED TO OTHER HERNIA ABOVE UMBILICUS, MAKING THIS A VENTRAL HERNIA REPAIR. A VENTRALEX ST WAS THEN PLACED AS AN UNDERLAY PATCH UNDER THE FASCIA WITH SOME OMENTUM BEHIND THE MESH AND SUTURED THROUGH THE MARLEX SIDE OF THE MESH.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALEX ST (DEVICE #1) AND IMPLANT OF PHASIX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿LYSIS OF SOME ADHESIONS OFF THE OLD MESH (DEVICE #1) WAS PERFORMED AND EXCISED THE MESH COMPLETELY. THE HERNIA DEFECT WAS IDENTIFIED AND DID A COMPONENT SEPARATION. A PHASIX MESH (DEVICE #2) WAS THEN TRIMMED, PLACED IN THE RETRORECTUS SPACE AND SUTURED.¿ ON (B)(6) 2016 - PATIENT UNDERWENT INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS. PER OPERATIVE NOTES, ¿SOME SUTURES WERE REMOVED IN THE SUBCUTANEOUS AND THE ABSCESS POCKET W

  Patient problems: Abscess

  MAUDE report 20201984 ↗
• InjuryJan 23, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC ¿ OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST (DEVICE #1). PER OPERATIVE NOTES, "AN OBLIQUE INCISION WAS MADE DOWN THROUGH THE PREVIOUS MESH AND A DEFECT WAS NOTED WITH A LARGE PIECE OF OMENTUM INCARCERATED WITHIN HERNIA, THIS WAS RESECTED ALONG WITH THE SAC. THE SMALL BOWEL WAS REDUCED INTO THE ABDOMINAL CAVITY. A CIRCULAR PIECE OF VENTRIO ST MESH (DEVICE #1) WAS PLACED IN THE ABDOMINAL CAVITY AND TACKED TO THE ANTERIOR ABDOMINAL WALL. THEN THE OLD MESH AND EXTERNAL OBLIQUE WAS CLOSED." (NOTE, NO PRODUCT IDENTIFIERS FOUND FOR THE PREVIOUS MESH) ON (B)(6) 2014 - PATIENT VISITED HOSPITAL FOR ABDOMINAL PAIN AND FEVER. ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INFECTED MESH WITH RECURRENT INCISIONAL HERNIA, SEPSIS THEREBY UNDERWENT COMPONENT SEPARATION, HERNIA REPAIR WITH REMOVAL OF THE MESH (DEVICE #1) AND IMPLANTED WITH PHASIX MESH (DEVICE #2). PER OPERATIVE NOTES, "WE WERE ABLE TO IDENTIFY SEVERAL LAYERS OF MESH AS OVERLAY WELL INCORPORATED INTO THE FASCIA. ON DISSECTION, WE WERE ABLE TO IDENTIFY INFECTED MESH (DEVICE #1) AND WAS EX

  Patient problems: Hernia

  MAUDE report 18562545 ↗
• InjuryJan 19, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRIO ST AND 20×25 PHASIX MESH ON (B)(6) 2021 AND/OR (B)(6) 2022. 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: Insufficient Information

  MAUDE report 18541949 ↗
• MalfunctionDec 12, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED, DURING HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2023, THE SURGEON TRIMMED THE PHASIX FLAT MESH (NON-COATED VERSION) TO ABOUT 3 X 6 INCHES AND IMPLANTED IN THE PATIENT. THE DOCTOR REPORTS HE HAS SEEN THE PATIENT POST-SURGERY, AND THE PATIENT IS DOING WELL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311430 ↗
• InjuryNov 23, 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 PHASIX ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PHASIX. 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

  MAUDE report 18197643 ↗
• MalfunctionSep 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING COMPLEX ABDOMINAL WALL RECONSTRUCTION, A HAIR WAS FOUND IN THE STERILE CONTENTS OF THE PHASIX FLAT MESH. IT WAS REPORTED THAT ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788697 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH TWO PHASIX MESH (DEVICE #1 AND DEVICE #2) BILATERALLY ON (B)(6) 2022. IT WAS REPORTED THAT POST IMPLANT, THE PATIENT HAD LOST WEIGHT VOLUNTARILY AND AESTHETICALLY, WAS NOT HAPPY AND WANTED TO GO BACK TO PERMANENT (SILICONE OR SALINE) IMPLANTS. AS REPORTED DUE TO THE PATIENT¿S DISSATISFACTION, EIGHT MONTHS POST IMPLANT, THE PATIENT UNDERWENT SURGICAL INTERVENTION FOR REMOVAL OF THE MESH ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939061 ↗
• InjuryMay 26, 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 PHASIX MESH ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PHASIX MESH. 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

  MAUDE report 14508157 ↗
• InjuryJun 17, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX HERNIA PATCH ON (B)(6) 2011 AND PHASIX MESH ON (B)(6) 2015. 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: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 12015841 ↗
• InjuryMay 28, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF UNSPECIFIED BARD/DAVOL PHASIX MESH (X3) ON (B)(6) 2015 AND (B)(6) 2016. 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: Insufficient Information; Pain

  MAUDE report 11900595 ↗
• MalfunctionMar 4, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2021, THE SURGEON WAS SUTURING A BARD/DAVOL PHASIX FLAT MESH USING A NON-BARD/DAVOL PDS SUTURE AT THE NORTH AND SOUTH EDGES WHEN THE MESH TORE. AS REPORTED, THE MESH WAS REMOVED FROM THE PATIENT AND DISCARDED. ANOTHER PHASIX FLAT MESH WAS USED TO COMPLETE THE CASE WITH NO FURTHER ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11414800 ↗
• InjurySep 9, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A ROBOTIC RIVES PROCEDURE AND WAS IMPLANTED WITH A PHASIX MESH (20X25CM). AS REPORTED THE HERNIA HAD REOCCURRED AND THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020 TO FIX THE HERNIA. DURING THE PROCEDURE, THE SURGEON FOUND THAT THE POSTERIOR RECTUS SHEATH PULLED AWAY FROM THE PHASIX MESH, CASING ADHESIONS ON THE BOWEL AND THAT THE PHASIX MESH THEN HAD A CENTRAL FAILURE, RESULTING IN THE RECURRENCE. AS REPORTED, A VENTRIO ST MESH WAS PULLED FROM THE HOSPITAL SHELF AND USED FOR REINFORCEMENT OF THE RECURRENT HERNIA. THE SURGEON PLACED THE VENTRIO ST MESH IN THE PATIENT AND THEN USED A NON-BARD/DAVOL FIXATION SYSTEM TO PLACE 33 TACKS THROUGH THE OUTER POCKET AND INTO THE PATIENT.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 10507753 ↗
• InjuryJan 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED PER (B)(6) CLINICAL STUDY (B)(6): ON (B)(6) 2014 THE SUBJECT PATIENT UNDERWENT REPAIR OF A PRIMARY MIDLINE INCISIONAL HERNIA USING BARD PHASIX MESH. AN ONLAY PLACEMENT WITHOUT COMPONENT SEPARATION TECHNIQUE WAS UTILIZED. THE LENGTH OF THE DEFECT MEASURED 30CM AND THE WIDTH MEASURED 10CM. IN ADDITION TO THE HERNIA REPAIR, A PANNICULECTOMY, LYSIS OF ADHESIONS, ABDOMINOPLASTY AND REMOVAL OF XIPHOID EXOSTOSIS WAS PERFORMED. PERIMETER FIXATION WAS PERFORMED WITH ABSORBABLE MONOFILAMENT SUTURE, 13 POINTS OF FIXATION WERE MADE. THE WOUND AND FASCIA WERE CLOSED. SKIN IS RECORDED AS FULLY CLOSED. ON (B)(6) 2015 THE SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENT MIDLINE HERNIA. ON (B)(6) 2015 THE SUBJECT PATIENT UNDERWENT ADDITIONAL SURGERY TO REPAIR THE RECURRENT HERNIA. AS REPORTED, POSSIBLE CONTRIBUTORS TO THE RECURRENCE ARE AS DOCUMENTED: "POSSIBLE MESH TEAR NOT ABLE TO CONFIRM DUE TO MESH IS COMPLETELY DISSOLVED." AND " XIPHOID BONE REMOVED DURING PRIMARY SURGERY, POSSIBLY WEAKENED AREA." THE HERNIA RECURRENCE WAS REPORTED TO HAVE BEEN LOCATED IN THE MIDDLE OF THE MESH. THE RECURRENT HERNIA HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITEL

  Patient problems: Hernia

  MAUDE report 9570383 ↗
• InjuryOct 24, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A HERNIA RECURRENCE NI/NI/2000: SUBJECT PATIENT UNDERWENT AN UNSPECIFIED HERNIA REPAIR. NI/NI/2011: SUBJECT PATIENT UNDERWENT REPAIR OF HERNIA WITH IMPLANT OF A NON BARD-DAVOL MESH (BIOLOGIC). (B)(6) 2014: THE SUBJECT PATIENT UNDERWENT A REPAIR OF A RECURRENT VENTRAL HERNIA WITH EXPLANT OF THE NON BARD-DAVOL MESH (BIOLOGIC) AND IMPLANT OF A BARD-DAVOL PHASIX FLAT MESH. THE SURGICAL PROCEDURE PERFORMED WAS A RETRO-RECTUS WITH CST USING POSTERIOR TECHNIQUE. THE DEFECT LENGTH WAS 20CM IN LENGTH AND 15CM IN WIDTH. LYSIS OF ADHESIONS WAS PERFORMED AT THIS TIME. PERIMETER FIXATION WAS PERFORMED WITH ABSORBABLE MONOFILAMENT SUTURE WITH 10 FIXATION POINTS. THE FASCIA WAS RE-APPROXIMATED AND THE SKIN WAS FULLY CLOSED. (B)(6) 2016: THE SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENT VENTRAL HERNIA. (B)(6) 2019: THE SUBJECT PATIENT UNDERWENT REPAIR OF A 3X RECURRENT VENTRAL HERNIA WITH INCARCERATION. A NON BARD-DAVOL MESH (BIOLOGIC) WAS IMPLANTED AT THIS TIME. OPERATIVE FINDINGS INDICATE A LARGE RECURRENT VENTRAL HERNIA IN THE UPPER MIDLINE AND A SMALLER LATERAL VENTRAL HERNIA WAS IDENTIFIED IN THE LEFT LOWER SIDE OF TH

  Patient problems: Hernia

  MAUDE report 9232642 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO IS PART OF A CLINICAL STUDY (PHASIX DVL-HE-011) EXPERIENCED A HERNIA RECURRENCE ON (B)(6) 2014 - THE SUBJECT PATIENT UNDERWENT REPAIR OF A MIDLINE PRIMARY INCISIONAL HERNIA WITH THE IMPLANT OF A PHASIX MESH. THIS WAS A RETRO-RECTUS REPAIR WITHOUT COMPONENT SEPARATION TECHNIQUE. ABSORBABLE MONOFILAMENT SUTURE WAS USED FOR FIXATION OF THE MESH. THE FASCIA AND SKIN WERE FULLY CLOSED. ON (B)(6) 2018 - THE SUBJECT PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE. THIS ADVERSE EVENT HAS BEEN ASSESSED AS MILD SEVERITY, POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE INDEX PROCEDURE. NO ACTION HAS BEEN TAKEN AT THIS TIME, CONDITION IS LISTED AS ONGOING.

  Patient problems: Hernia

  MAUDE report 7973590 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT WAS REPORTED VIA POST MARKET CLINICAL STUDY. ON (B)(6) 2016 THE PATIENT UNDERWENT THE REPAIR OF AN INFRAUMBILICAL HERNIA WITH 2 STOMAS PRESENT AND WAS IMPLANTED WITH A DAVOL PHASIX MESH. AN ENDOSCOPIC RETRO-RECTUS WITH COMPONENT SEPARATION TECHNIQUE AND REMOVAL OF EXCESS SKIN WERE PERFORMED. THE WOUND AND FASCIA WERE CLOSED WITH ABSORBABLE SUTURE. THE SKIN WAS FULLY CLOSED. ON (B)(6) 2017 DURING A FOLLOW UP VISIT THE PATIENT WAS NOTED TO TO HAVE A NORMAL SCAR, SMALL PERISTOMAL HERNIA (ASSESSED BY THE CLINICIAN AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE) AT SIMOIDEOSTOMY, AND A NORMAL UROSOTMY. THE PATIENT EXPERIENCED DAILY VOMITING AND ABDOMINAL COLIC PAIN FROM MID APRIL 2018. IT IS NOTED THAT THE VOMITING MIGHT BE CAUSED BY ADHESIONS AS A RESULT OF SURGERY. ON 04/15/2018 THE PATIENT WAS DIAGNOSED WITH A RECURRENCE OF THE INCISIONAL HERNIA. THE EVENT IS ASSESSED BY THE CLINICIAN AS ONGOING, SEVERE AND POSSIBLY RELATED TO THE DEVICE. THE EVENT IS ASSESSED BY THE CLINICIAN AS DEFINITELY RELATED TO THE PROCEDURE. ON (B)(6) 2018 THE PATIENT HAD BECOME SEVERELY DEHYDRATED AND WAS ADMITTED TO HER LOCAL HOSPITAL FOR EVALUATION AND RE-HYDRATION. SHE WAS DISCHARGED

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 7616109 ↗
• InjuryApr 19, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2014 - THE PATIENT UNDERWENT A SYMPTOMATIC INCISIONAL HERNIA REPAIR PROCEDURE A VENTRALIGHT ST WITH ECHO PS (DEVICE 1) WAS IMPLANTED IN THE PATIENT¿S PERITONEAL CAVITY TO REINFORCE TISSUE AFFECTED BY THE HERNIA. ON (B)(6) 2015 - THE PATIENT UNDERWENT A SUBSEQUENT SURGERY TO REPAIR A RECURRENT RIGHT EPIGASTRIC INCISIONAL HERNIA. IT WAS DURING THIS SURGERY THAT ANOTHER VENTRALIGHT ST WITH ECHO PS (DEVICE 2) WAS IMPLANTED INTO THE PATIENT TO CORRECT WHAT WAS SEEN TO BE A COMPLEX HERNIA WHERE THE PREVIOUS MESH WAS ¿WRINKLED UP TO THE RIGHT SIDE OF THE ABDOMINAL WALL.¿ ON (B)(6) 2016 - THE PATIENT UNDERWENT A THIRD SURGERY TO REPAIR A COMPONENT SEPARATION VENTRAL INCISIONAL HERNIA. IT WAS DURING THIS THIRD SURGERY THAT A PHASIX MESH (DEVICE 3) WAS IMPLANTED INTO THE PATIENT. DURING THIS PROCEDURE, BOTH VENTRALIGHT ST MESH¿S THAT WERE IMPLANTED IN PATIENT "IN 2014 AND 2015, RESPECTIVELY, WERE REPAIRED AND REMOVED FROM PATIENT¿S ABDOMEN." DOCTOR "CHOSE TO EXCISE ONE MESH PRODUCT IN ITS ENTIRETY, WHILE ONLY REMOVING HALF OF THE OTHER MESH." AS REPORTED, "TO THIS DAY, ONE HALF OF THE VENTRALIGHT ST WITH ECHO PS REMAINS IMPLANTED

  Patient problems: Disability; Hernia; Injury

  MAUDE report 7444512 ↗