Phasix 1190300Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741077685), received between Oct 2, 2017 and Jun 16, 2026 — classified as 2 deaths, 18 injuries.

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Use of Device Problem

  AS REPORTED ON (B)(6) 2026, THE PATIENT WAS IMPLANTED WITH A PHASIX MESH. AS REPORTED, THE MESH WAS USED IN AN "INFECTED HERNIA CASE." REPORTEDLY, TWO (2) MONTHS POST IMPLANTATION THE PHASIX MESH WAS REMOVED DUE TO SEVERE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 25525225 ↗
• InjuryMay 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "INCISION WAS MADE AROUND THE UMBILICAL REGION. A PERFIX PLUG AND PATCH (DEVICE 1) WAS PLACED INTO THE DEFECT USING PROLENE SUTURES." (B)(6) 2012 - PATIENT HAD PARTIAL SMALL BOWEL OBSTRUCTION AND ABDOMINAL PAIN. (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA AND INFECTED ABDOMINAL WALL MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, "EROSION OF SMALL BOWEL TO MESH AT THE UMBILICUS WITH ENTEROCUTANEOUS FISTULA. LOOP OF BOWEL STUCK UP TO THE BACKSIDE OF IT THAT WAS FISTULIZED TO THE MESH AND THE MESH (DEVICE 1) WAS REMOVED. A PHASIX MESH (DEVICE 2) WAS PLACED INTO THE WOUND." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WOUND INFECTION THEREBY UNDERWENT INCISION AND DRAINAGE OF ABDOMINAL WOUND. PER OP NOTES, "PATIENT HAD A HEMATOMA AND WAS EVACUATED. AT THE BASE OF THE WOUND WAS A PIECE OF MESH (DEVICE 2) THAT WAS SUTURED TO THE PATIENT ABDOMEN."

  Patient problems: Hematoma; Wound Infection

  MAUDE report 25333464 ↗
• InjuryApr 1, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1) AND VENTRALEX MESH (DEVICE 2). PER OP NOTES, "PREVIOUS INCISION OVER THE PATIENT'S EPIGASTRIC HERNIA, A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED IN THE ABDOMINAL CAVITY USING PROLENE SUTURES. ATTENTION WAS THEN TURNED TO THE UMBILICUS WHERE A SUPRAUMBILICAL INCISION WAS MADE, A VENTRALEX MESH (DEVICE 2) WAS PLACED IN THE DEFECT USING PROLENE SUTURES." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL UMBILICAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2) AND IMPLANT OF PHASIX MESH (DEVICE 3). PER OP NOTES, "PATIENT'S PREVIOUS MIDLINE INCISION WAS EXTENDING TO THE LEVEL OF THE UMBILICUS. THERE WAS A DEFECT PRESENT IN THE FASCIA AS WELL AS MESHOMA, THE PRIOR MESH (DEVICE 1) CONTRACTED INTO A MASS, THIS WAS DISSECTED. THERE WERE OMENTAL ADHESIONS OF THE PTFE SURFACE OF THE MESH, THESE WERE TAKEN DOWN. PALPATED THE AREA OF THE UMBILICUS, THERE WAS THE PREVIOUSLY PLACED UMBILICAL MESH. THIS UMBILICAL MESH (DEVICE 2) WAS ALSO DISSECTED OUT. A PHASIX MESH (DEVICE 3) WA

  Patient problems: Hernia

  MAUDE report 24756703 ↗
• InjuryMar 9, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH VENTRAL ABDOMINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, "A LARGE HERNIA SAC WAS IDENTIFIED AND WAS EXCISED. A MEDIUM SIZED COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED TO THE ABDOMINAL CAVITY USING SUTURES." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA WITH STRANGULATED SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT REPAIR WITH REMOVAL OF OLD MESH (DEVICE 1), LYSIS OF ADHESIONS AND RESECTION OF THE SMALL BOWEL. PER OP NOTES, "SMALL BOWEL WAS DENSELY ADHERENT TO THE OLD MESH. LYSIS OF ADHESIONS WAS PERFORMED, THE OLD MESH (DEVICE 1) WAS REMOVED." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LARGE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, "A VERTICAL INCISION WAS MADE IN THE ABDOMEN, A PHASIX MESH (DEVICE 2) WAS PLACED USING SUTURES." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL SEROMA THEREBY UNDERWENT INCISION AND DRAINAGE, DEBRIDEMENT OF THE ABDOMINAL WALL AND MESH REMOVAL (DEVICE 2). PER OP NOTES, "ELLIPTICAL INCISION WAS MADE IN THE ABDOMEN, THE MESH (DEV

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 24543290 ↗
• InjuryDec 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿VENTRAL HERNIA WAS IDENTIFIED. A VENTRALEX MESH (DEVICE 1) WAS PLACED INFERIOR TO FASCIAL EDGES AND SECURED ON ALL SIDES USING SUTURES.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS, MESH EROSION, BOWEL PERFORATION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, ¿ABSCESS WAS DRAINED. THERE WAS A PERFORATION OF THE SMALL BOWEL WITH MESH (DEVICE 1) ERODING INTO THE SMALL BOWEL. ADHESIONS WERE LYSED. LOOPS WHICH WERE INVOLVED WITH MESH EROSION WAS RESECTED. ONLAY PHASIX MESH (DEVICE 2) WAS PLACED AND SECURED USING SUTURE.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH NECROTIC WOUND THEREBY UNDERWENT DEBRIDEMENT OF NECROTIC WOUND. ON (B)(6) 2021 ¿ PATIENT WAS DIAGNOSED WITH NONHEALING SURGICAL WOUND THEREBY UNDERWENT SCAR REVISION AND REMOVAL OF MESH (DEVICE 2). PER OP NOTES, ¿INCISION WAS MADE TO REMOVE ENTIRE AREA AND TO REDUCE PUCKERING INCORPORATING WOUND. THERE WAS STILL SOME PHASIX MESH (DEVICE 2) WAS CURETTED OFF.¿

  Patient problems: Abscess; Impaired Healing; Necrosis; Scar Tissue

  MAUDE report 23848259 ↗
• InjuryApr 30, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER PLAINTIFF PROFILE FORM (B)(4): ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, ADHESIONS, MESH MIGRATION, MESH SHRINKAGE, PAIN, HERNIA RECURRENCE WOUND VAC PLACED AND DRAIN PLACED. PER INFORMATION PROVIDED: ON (B)(6) 2015- PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX MESH (DEVICE #1), SMALL BOWEL RESECTION AND BILATERAL COMPONENT SEPARATION. PER OPERATIVE NOTES, "A SUBSTANTIAL DEFECT WAS NOTED AND A PRIMARY FASCIAL CLOSURE WAS PERFORMED. A BIOLOGIC MESH WAS PLACED AS IN FASCIAL UNDERLAY POSITION. A PHASIX MESH (DEVICE #1) WAS PLACED IN FASCIAL OVERLAY FASHION AND SECURED CIRCUMFERENTIALLY." ON (B)(6) 2016- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, "INCISION MADE SHARPLY OVERLYING THE FASCIAL DEFECT CARRIED DOWN TO THE SAC AND OPENED. LYSIS OF ADHESIONS WAS PERFORMED. THE DEFECT WAS NOTED AND A VENTRIO ST MESH (DEVICE #2) WAS PLACED AND SUTURED. THE FASCIA WAS REAPPROXIMATED WITH SUTURE THROUGH THE IMMEDIATE UNDERLAY MESH (DEVICE #1)." ON (B)(6) 2016- PATIENT WAS DIAGN

  Patient problems: Abscess; Necrosis; Purulent Discharge; Unspecified Infection

  MAUDE report 21938257 ↗
• InjuryApr 30, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER PLAINTIFF PROFILE FORM (B)(4): ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, ADHESIONS, MESH MIGRATION, MESH SHRINKAGE, PAIN, HERNIA RECURRENCE WOUND VAC PLACED AND DRAIN PLACED. PER INFORMATION PROVIDED: (B)(6) 2015- PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX MESH (DEVICE #1), SMALL BOWEL RESECTION AND BILATERAL COMPONENT SEPARATION. PER OPERATIVE NOTES, "A SUBSTANTIAL DEFECT WAS NOTED AND A PRIMARY FASCIAL CLOSURE WAS PERFORMED. A BIOLOGIC MESH WAS PLACED AS IN FASCIAL UNDERLAY POSITION. A PHASIX MESH (DEVICE #1) WAS PLACED IN FASCIAL OVERLAY FASHION AND SECURED CIRCUMFERENTIALLY." (B)(6) 2016- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, "INCISION MADE SHARPLY OVERLYING THE FASCIAL DEFECT CARRIED DOWN TO THE SAC AND OPENED. LYSIS OF ADHESIONS WAS PERFORMED. THE DEFECT WAS NOTED AND A VENTRIO ST MESH (DEVICE #2) WAS PLACED AND SUTURED. THE FASCIA WAS REAPPROXIMATED WITH SUTURE THROUGH THE IMMEDIATE UNDERLAY MESH (DEVICE #1)." (B)(6) 2016- PATIENT WAS DIAGNOSED WITH

  Patient problems: Abscess; Adhesion(s); Hernia; Necrosis; Obstruction/Occlusion; Purulent Discharge; Unspecified Infection

  MAUDE report 21938193 ↗
• DeathApr 10, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2005: PATIENT WAS DIAGNOSED WITH LARGE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF THE COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS EXCISED. LYSIS OF ADHESIONS WAS PERFORMED, AND A LARGE PIECE OF COMPOSIX KUGEL MESH (DEVICE #1) WAS PLACED AND TACKED UNDERSURFACE OF PERITONEUM CIRCUMFERENTIALLY.¿ ON (B)(6) 2007 TO ON (B)(6) 2010: PATIENT HAD ABDOMINAL PAIN. ON (B)(6) 2016: PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS SECONDARY TO BOWEL FISTULA WITH MESH THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF OLD MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE MESH (DEVICE #1) WAS DISSECTED CIRCUMFERENTIALLY FROM THE ABDOMINAL WALL. FISTULA WAS FOUND IN THE SMALL BOWEL WHERE THERE WAS FRANK BILE STAINED MESH ON THE LEFT LATERAL ASPECT AND CAREFULLY DISSECTED THIS BOWEL. LYSIS OF ADHESIONS WAS PERFORMED THAT WAS INTIMATELY INVOLVED WITH MESH AND THEN RE-ANASTOMOSIS.¿ ON (B)(6) 2016: PATIENT WAS DIAGNOSED WITH PAIN, LONG STANDING ABDOMINAL WALL MESH ABSCESS THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF XENMATIX AB GRAFT (DEVICE #2) AND PHASIX MESH (DEVICE #3). PER OPERATIVE NOTES, ¿

  Patient problems: Bowel Perforation; Cellulitis; Fasciitis; Fistula; Inflammation; Peritonitis

  MAUDE report 19077131 ↗
• InjuryJan 22, 2024Defective 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 VENTRIO ST AND PHASIX MESH ON (B)(6) 2020 AND/OR (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: Insufficient Information

  MAUDE report 18549874 ↗
• InjuryNov 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Patient-Device Incompatibility; Incorrect, Inadequate or Imprecise Result or Readings; Patient-Device Incompatibility

  AS ALLEGED, THE PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE WITH THE IMPLANT OF PHASIX FLAT MESH ON (B)(6) 2020. ALLEGEDLY, ON (B)(6) 2020 AND (B)(6) 2020 THE PATIENT UNDERWENT SURGERY TO CLEAN OUT THE ABDOMINAL AREA. ON (B)(6) 2021 THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE LOWER ABDOMINAL AREA FROM THE BELLY BUTTON DOWN. AS ALLEGED, THE MESH NECROTIZED IN THE ABDOMINAL WALL CAUSING SEROMAS, PATIENT HAD SEVERAL JP DRAINS PLACED AND HAD SEVERAL INFECTIONS WHICH WERE TREATED WITH ANTIBIOTICS. IT IS ALLEGED THAT THE PATHOLOGY REPORTS SHOW NECROTIC MESH REMOVED IN ALL THE SURGERIES. IT WAS REPORTED THAT POST IMPLANT THE MESH DID NOT DISSOLVE AND HAD TO BE REMOVED. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL MASS CONSISTENT WITH RECURRENT METASTATIC CERVICAL CARCINOMA, VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH. PER OPERATIVE NOTES, ¿THE MASS WAS LOCATED JUST TO THE RIGHT OF THE MIDLINE AND COMPLETELY REMOVED. A PIECE WAS PHASIX MESH WAS THEN PLACED IN AN ONLAY TYPE FASHION, TACKED IN A CIRCUMFERENTIAL MANNER AND SUTURED.¿ ON (B)(6) 2020 - PATIENT HAD UNHEALED ABDOMINAL WOUND A

  Patient problems: Abscess; Impaired Healing; Necrosis; Scar Tissue; Seroma; Unspecified Infection

  MAUDE report 18220438 ↗
• InjuryJun 14, 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) 2016. 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: Insufficient Information; Pain; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 17124347 ↗
• InjuryFeb 13, 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 PHASIX MESH ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD 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: Insufficient Information; Pain; Seroma

  MAUDE report 16362472 ↗
• InjuryAug 31, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED THAT THE PATIENT UNDERWENT SURGERY OF IMPLANT ON PHASIX MESH ON (B)(6) 2018. THE REPORTER WANTS TO KNOW WHAT MATERIAL THE PHASIX MESH IS MADE OF, SPECIFICALLY HOW THE BODY ABSORBS THE MESH, IF THE MESH CAN TRAVEL TO THE LUNGS, AND HOW LONG IT TAKES TO LEAVE THE BODY. AS REPORTED, THE PHASIX MESH WAS USED IN THE PATIENT'S BREAST RECONSTRUCTION WITH GEL IMPLANTS. THE REPORTER QUESTIONED ¿IF PHASIX GOES INTO THE LUNGS, WHILE IT IS IN THE LUNGS DOING WHATEVER, CAN IT SHOW UP AS LUNG NODULES OR [IF] SIDE EFFECTS OF THIS [NATURE] BEEN REPORTED¿. PER THE REPORTER, IT APPEARED THAT THE PATIENT HAS CONCERN WITH PHASIX BEING ABSORBED INTO HER BODY, SHE SUSPECTS IT HAS CAUSED HER TO HAVE LUNG CANCER, HOWEVER, WHEN QUESTIONED, THE REPORTER DID NOT CONFIRM THAT THE PATIENT DOES HAVE LUNG CANCER. THE REPORTER INDICATED THE PATIENT BELIEVES THE MESH HAS CAUSED HER TO HAVE A PLACE ON HER LUNGS AND THAT IS WHY THE REPORTER IS ASKING SO MANY QUESTIONS AND GATHERING DETAILS ABOUT THE PRODUCT. DURING A SUBSEQUENT FOLLOW UP CONVERSATION WITH THE REPORTER, WHEN ASKED DIRECTLY IF THE PATIENT HAD AN ISSUE TO REPORT OR AN ADVERSE EVENT ASSOCIATED WITH THE MESH, THE REPORTER CONFIRMED THE PATIEN

  Patient problems: Nodule

  MAUDE report 12393693 ↗
• InjurySep 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A BD/DAVOL PHASIX MESH IN (B)(6) 2020. IT IS ALLEGED THAT THE PATIENT HAD A JACKSON-PRATT (JP) DRAIN FOR 10 MONTHS AND HAS BEEN SICK SINCE THE IMPLANT OF THE MESH. THE DRAIN WAS REMOVED AND A SEROMA WAS IDENTIFIED. IT IS ALSO ALLEGED THAT THERE WAS A HOLE IN THE ABDOMEN WITH DRAINAGE AND NECROTIC TISSUE WAS FOUND, AND SURGERY WAS DELAYED DUE TO COVID-19. THE MESH WAS LATER EXPLANTED AND THE PATIENT HAS A 7 INCH SCAR. AS REPORTED, THE PATIENT HAS ISSUES WITH THE PHASIX HERNIA MESH (INFECTION AND NECROSIS) AND ALSO THAT THE MESH DID NOT DISINTEGRATE, CAUSING THE PATIENT TO GET SICK.

  Patient problems: Necrosis; Seroma; Unspecified Infection

  MAUDE report 10606647 ↗
• InjuryJan 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2014 THE SUBJECT PATIENT UNDERWENT REPAIR OF A MIDLINE HERNIA UTILIZING BARD PHASIX MESH. AN ONLAY PLACEMENT WITHOUT COMPONENT SEPARATION TECHNIQUE WAS PERFORMED. THE HERNIA DEFECT MEASURED 15CM IN LENGTH AND 12CM IN WIDTH. THIS PROCEDURE WAS PERFORMED IN CONJUNCTION WITH CREATION OF BILATERAL SUBCUTANEOUS TISSUE FLAPS. PERIMETER FIXATION WAS COMPLETED WITH ABSORBABLE MONOFILAMENT SUTURE WITH 12 FIXATION POINTS. THE FASCIA WAS RE-APPROXIMATED AND THE SKIN WAS FULLY CLOSED. ON (B)(6) 2017 THE SUBJECT PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE. THE RECURRENCE HAS BEEN ASSESSED PER THE CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED BY THE CLINICIAN AS MODERATE SEVERITY WITH AN ONGOING RESOLUTION DATE. NO ACTION HAS BEEN TAKEN. AS REPORTED THAT A PROTOCOL DEVIATION OCCURRED AT THE TIME OF IMPLANT ON (B)(6) 2014 AS THE HERNIA DEFECT MEASURED 15CMX12CM AND PHASIX MESH USED TO TREAT THE HERNIA MEASURED 15.2CM X 20.3CM WAS NOT WITHIN GUIDELINES FOR AT LEAST 5CM MARGIN OVER DEFECT

  Patient problems: Hernia

  MAUDE report 9574213 ↗
• InjuryMay 1, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  PHYSICIAN (CARDIOLOGIST) WHO IS CURRENTLY SEEING A PATIENT WHO HAS PRESENTED WITH SUSPECTED AUTO-IMMUNE TYPE SYMPTOMS INQUIRED ABOUT THE PHASIX MESH AND IF THERE ARE ANY KNOWN CASES IN WHICH THIS MESH HAS BEEN INVOLVED IN CAUSING OR CONTRIBUTING TO AUTO-IMMUNE DISORDERS SUCH AS LUPUS OR RAYNAUD' PHENOMENON. AS REPORTED, PER PHYSICIAN: THE PATIENT UNDERWENT IMPLANT OF A PHASIX MESH APPROXIMATELY 6 MONTHS AGO. THE PATIENT HAS SINCE DEVELOPED SYMPTOMS CLOSELY RELATED TO THOSE OF REYNAUD'S PHENOMENON. DOCTOR HAS DESCRIBED SYMPTOMS OF VASOREACTIVITY IN WHICH THE FINGERS ARE REACTING WHEN EXPOSED TO WARM TEMPERATURES (VS. COLD TEMPERATURE). THE PATIENT'S BLOOD SEROLOGY WAS NEGATIVE FOR LUPUS AND THERE HAS BEEN NO DEFINITIVE DIAGNOSIS MADE AT THIS TIME. DOCTOR STATES HE CANNOT RULE OUT THE MESH AS A CONTRIBUTING FACTOR AS THE PATIENT DOES NOT HAVE A HISTORY OF AUTO-IMMUNE DISORDERS OR ALLERGIES. THE DOCTOR WAS NOT INTERESTED IN A SURGEON TO SURGEON CONSULT AT THIS TIME, ALTHOUGH THIS WAS OFFERED. DOCTOR ALSO DID NOT WANT TO PURSUE A MESH SKIN PATCH TEST AS HE STATED HE DID NOT FEEL THAT WOULD BE BENEFICIAL IN THIS PARTICULAR CASE.

  Patient problems: Autoimmune Reaction; Raynauds Phenomenon; Reaction

  MAUDE report 8568689 ↗
• InjuryNov 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO IS PART OF A CLINICAL STUDY ((B)(46)) EXPERIENCED A HERNIA RECURRENCE ON (B)(6) 2015 - THE SUBJECT PATIENT UNDERWENT THE REPAIR OF A MIDLINE INCISIONAL HERNIA USING THE PHASIX MESH. ABSORBABLE MONOFILAMENT SUTURES WERE USED TO FIXATE THE MESH AND THE FASCIA/SKIN WERE FULLY CLOSED. ON (B)(6) 2017 - THE SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENT MIDLINE INCISIONAL HERNIA. THIS ADVERSE EVENT WAS ASSESSED AT THIS TIME, AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. ON (B)(6) 2018 - THE SUBJECT PATIENT UNDERWENT REPAIR OF THE RECURRENT HERNIA (PRIMARILY WITH NO MESH), WITH EXPLANT OF THE PHASIX MESH. THE FASCIA/SKIN WERE FULLY CLOSED. AS REPORTED, THE REASON FOR THE HERNIA RECURRENCE WAS "POOR HEALING/POOR ADHESION DEVELOPMENT."

  Patient problems: Hernia

  MAUDE report 8037027 ↗
• InjuryAug 21, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY PER LEGAL LETTER: ON (B)(6) 2017: THE PATIENT HAD DEVELOPED AN INCISIONAL HERNIA THAT WAS GRADUALLY GETTING BIGGER. PLAN WAS TO DO A LAPAROSCOPIC REPAIR. ON (B)(6) 2017: THE SURGERY PERFORMED WAS A LAPAROSCOPIC VENTRAL INCISIONAL HERNIA REPAIR WITH MESH AND LYSIS OF ADHESIONS. THE MESH THAT WAS ORIGINALLY IMPLANTED WAS A BARD/DAVOL PHASIX. ON (B)(6) 2017: THE SURGICAL NOTE MADE BY PHYSICIAN, "INFORMED BY BARD REP YESTERDAY THAT MESH USED WAS NOT APPROPRIATE FOR INTRAABDOMINAL USE." THE PATIENT WAS INFORMED AND THE PLAN WAS TO IMMEDIATELY REMOVE AND REPLACE THE MESH TO AVOID ANY FURTHER COMPLICATIONS. THE INCORRECT MESH USED ON (B)(6) 2017 DID NOT HAVE AN ADHESION BARRIER; THUS, THE PATIENT WAS AT RISK FOR EROSION INTO THE BOWEL. THE MESH IMPLANT THAT WAS USED AS A REPLACEMENT WAS A NON-BARD/DAVOL MESH. THIS MESH IS DESIGNED FOR HERNIA REPAIR. ON (B)(6) 2017: THE PATIENT WAS DISCHARGED. THE OPERATIVE REPORT STATES THAT THEY "OPTED TO RETURN HER TO SURGERY AS SOON AS POSSIBLE IN ORDER TO MINIMIZE HER RECOVERY." HOWEVER, THE PATIENT'S RECOVERY TIME WOULD NOT HAVE BEEN AT ISSUE HAD THE APPROPRIATE MESH BEEN IMPLANTED DURING THE FIRST

  Patient problems: Pain

  MAUDE report 7803233 ↗
• DeathJun 11, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2013: THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL PHASIX MESH FOR THE REPAIR OF AN INCISIONAL HERNIA. ON (B)(6) 2015: THE PATIENT STARTED EXPERIENCING PAIN RADIATING FROM HIS ABDOMEN AND NEUROPATHY. THEREAFTER, THE PATIENTS PHYSICIANS ELECTED FOR A REPAIR SURGERY OF THE HERNIA AND HERNIA MESH. UPON ENTERING THE ABDOMINAL CAVITY, THE PATIENTS SURGEON NOTED THAT THE BARD/DAVOL PHASIX MESH HAD FAILED AND REMOVED PART OF THE MESH. IT IS ALLEGED THAT SUBSEQUENT TO THE BARD/DAVOL PHASIX MESH IMPLANT SURGERY, THE PATIENT SUFFERED SUBSTANTIAL PAIN AND SUFFERING AND HAS NOT BEEN ABLE TO RECEIVED PROPER CARE FOR HIS ESOPHAGUS CANCER BECAUSE PHYSICIANS WERE UNABLE TO PLACE A FEEDING TUBE DUE TO THE MESH, AND SUBSEQUENTLY DIED.

  Patient problems: Death; Disability; Necrosis; Neuropathy; Pain; Unspecified Infection

  MAUDE report 7586470 ↗
• InjuryOct 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED PER CLINICAL STUDY COORDINATOR: ON (B)(6) 2016 THE PATIENT UNDERWENT REPAIR OF A "FIRST TIME RECURRENCE INCISIONAL MIDLINE HERNIA." A RETRO-RECTUS WITHOUT COMPONENT SEPARATION TECHNIQUE WAS PERFORMED. DRAINS WERE PLACED ON THE RIGHT UPPER AND LEFT LOWER QUADRANT. THE DRAINS WERE REMOVED ON (B)(6) 2016. A YEAR LATER ON (B)(6) 2017 THE PATIENT PRESENTED FOR HER 12 MONTH FOLLOW UP EXAMINATION WITH SUSPICION OF HERNIA RECURRENCE. ON (B)(6) 2017 THE PATIENT UNDERWENT A CT SCAN WHICH REVEALED A RECURRENT HERNIA. ON (B)(6) 2017 THE PATIENT UNDERWENT REPAIR OF THE HERNIA RECURRENCE. THIS WAS PERFORMED IN OPEN FASHION. A SANDWICH TECHNIQUE WAS PERFORMED WITH TWO UNSPECIFIED PERMANENT MESHES. THE HEALTH PROFESSIONAL NOTES THERE WAS SCAR FORMATION INDUCED BY THE PHASIX AND REMNANTS OF THE PHASIX COULD BE SEEN. THE PATIENT IS NOTED TO HAVE RECOVERED. THIS HERNIA RECURRENCE WAS ASSESSED PER THE HEALTH PROFESSIONAL AS A SERIOUS ADVERSE EVENT BEING POSSIBLY RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Hernia; Scar Tissue

  MAUDE report 6908523 ↗