Phasix 1190500Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00801741077708), received between Apr 26, 2017 and Aug 26, 2026 — classified as 37 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (21 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2012 - Patient was diagnosed with recurrent ventral hernia, incarcerated incisional hernia, thereby underwent open repair with explant of synthetic mesh, implant of Ventrio ST Mesh (Device 1). Per op notes, "Through a midline incision, previously placed synthetic mesh was identified and was dissected. Then a midline fascia was identified and repaired by placing a Ventrio ST Mesh (Device 1) into the defect and was sutured." (b)(6) 2013 - Patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with implant of Ventrio ST Mesh (Device 2). Per op notes, "Hernia defect in the abdominal region was identified and was dissected. A Ventrio ST Mesh (Device 2) was placed and secured in place with sutures to the previous mesh (Device 1) in the midline and was tacked to cover the entire defect."(b)(6) 2015 - Patient was diagnosed with recurrent ventral hernia, thereby underwent open repair. Per op notes, "Purulent drainage was noted from the middle portion of the midline incision site."(b)(6) 2016 - Patient was diagnosed with abdominal pain, thereby underwent repair with implant of biologic mesh. Extensive intra-abdominal small bowel

  Patient problems: Scar Tissue; Unspecified Infection

  MAUDE report 50459855 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  As reported, on (b)(6) 2026 during a robotic ventral hernia repair procedure the patient was implanted with Phasix Flat Mesh. As reported, the patient had a post-operative fever and the patient's wife called the surgeon multiple times reporting her concerns. There was no reported treatment provided by the surgeon. In follow up with the surgeon it is reported that, "the patient no longer has a fever and doing well."

  Patient problems: Fever

  MAUDE report 50456685 ↗
• InjuryFeb 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE MIDLINE, THREE DISCRETE DEFECTS IN A ROW WERE NOTED AND CONNECTED. THE FASCIA WAS CLOSED WITH SUTURES AND BARD FLAT MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SECURED WITH SUTURES.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF PRIOR MESH (DEVICE 1) AND IMPLANT OF XENMATRIX AB MESH (DEVICE 2) AND PHASIX MESH (DEVICE 3). PER OPERATIVE NOTES, ¿IN THE MIDLINE, THE PRIOR MESH (DEVICE 1) WAS HARDENED AND FILL THE VENTRAL HERNIA. ADHESIONS WERE LYSED AND HERNIA ONE ABOVE AND BELOW THE BELLYBUTTON WERE REDUCED. THE PRIOR MESH (DEVICE 1) WAS PARTIALLY REMOVED AND ABSCESS WAS DRAINED. THE XENMATRIX AB MESH (DEVICE 2) WAS PLACED OVER THE FASCIA AND REAPPROXIMATED WITH SUTURES. THE FASCIA WAS REINFORCED AND PHASIX MESH (DEVICE 3) WAS PLACED AND SECURED WITH SUTURES AND OPTIFIX TACKERS.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INFECTED WOUND THEREBY UNDERWENT INCISION AND DRAINAGE OF INFECTED WOUND AND SEROMA.

  Patient problems: Necrosis; Post Operative Wound Infection; Seroma

  MAUDE report 24452339 ↗
• InjuryFeb 14, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OP NOTES, "THE MIDLINE INCISION WAS MADE, A VENTRALEX ST MESH (DEVICE 1) WAS PLACED USING PROLENE SUTURES." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH EXPLANT OF OLD MESH (DEVICE 1) AND IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, "SCAR TISSUE WAS EXCISED, THE MESH (DEVICE 1) WAS REMOVED. TOOK DOWN ADHESIONS BETWEEN THE ANTERIOR ABDOMINAL WALL. A PHASIX MESH (DEVICE 2) WAS PLACED TO THE SYMPHYSIS PUBIS." (B)(6)2015 - PATIENT WAS DIAGNOSED WITH WOUND INFECTION THEREBY UNDERWENT INCISION AND DRAINAGE OF INFECTED ABDOMINAL WOUND. PER OP NOTES, "THE INFERIOR PORTION OF THIS HAD EXPOSED PHASIX MESH (DEVICE 2) THAT SEEMED TO BE WELL INCORPORATED."

  Patient problems: Post Operative Wound Infection

  MAUDE report 24340554 ↗
• InjuryAug 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT 2 INCISIONAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. A VENTRIO MESH (DEVICE #1) WAS PLACED JUST ABOVE THE UMBILICUS AND SECURE IT WITH SUTURE.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, ADHESION, SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF THE BARD VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. THE OLD MESH WAS FOLDED. BARD VENTRIO MESH (DEVICE #1) WAS PLACED AND SUTURED. VENTRIO ST MESH (DEVICE #2) WAS ANCHORED AT THE SUPERIOR AND LATERAL OLD VENTRIO MESH (DEVICE #1) TO PROVIDE POSITIONAL STABILITY.¿ ON (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH ACUTE RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REINFORCEMENT WITH BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿OLD MESH HAD CRUMPLES AND ROTATED. ONE BIOLOGICAL MESH WAS PLACED TO ABDOMEN AREA AND SECURE IT WITH SUTURE.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA, ADHESION, 5 INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH LYSIS

  Patient problems: Hernia; Purulent Discharge

  MAUDE report 22713664 ↗
• InjuryJul 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH INTESTINAL ADHESIONS WITH RECURRENT INCISIONAL HERNIA WITH AN UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED INTO OPEN REPAIR WITH IMPLANT OF COMPOSIX LP MESH (DEVICE #1). PER OPERATIVE NOTES,¿ ADHESIONS WERE REMOVED. THE HERNIAS WERE IDENTIFIED AND DISSECTED AND COMPOSIX LP MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ ON (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL WALL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF COMPOSIX LP MESH (DEVICE #1) AND IMPLANT OF ALLOMAX (DEVICE #2) MESH. PER OPERATIVE NOTES, ¿WOUND WAS CLOSED WITH SUTURES AND ALLOMAX (DEVICE #2) WAS PLACED AND SECURED WITH SUTURES. THE PREVIOUSLY PLACED MESH (DEVICE #1) IN THE FASCIA WAS NOTED. DENSE ADHESIONS OF BOWEL TO MESH (DEVICE #1) WAS REMOVED. THE COMPOSIX LP MESH (DEVICE #1) WAS DISSECTED AND REMOVED¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA IN SUBXIPHOID POSITION AND RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF WITH IMPLANT OF PHASIX FLAT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿THE INCISIONAL HERNIA DEFECT IN THE UPPER ABDOMEN WAS CLOSED WITH

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

  MAUDE report 22530603 ↗
• InjuryJul 17, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER MEDWATCH FORM (MW5155891): "HERNIA MESH IMPLANT RESULTING IN INFECTION REVISION SURGERY AND PROLONGED INFECTION. CR BARDMESH HRNA REPAIR 25CMX31CM IMPLANT TYPE: MESH/PEG, IMPLANTED AREA: ABDOMEN LATERALITY: N/A, IMPLANTED ON (B)(6) 2023. NUMBER IMPLANTED: 1 STATUS: IMPLANTED, MANUFACTURER CR BARD, MODEL NUMBER: 1190500, LOT NUMBER: HUGZ0902, SERIAL NUMBER: SEALNT PWDR HEMOS 3GM ARISTA IMPLANT TYPE SEALANT IMPLANTED AREA: ABDOMEN LATERALITY: N/A IMPLANTED ON (B)(6) 2023. NUMBER IMPLANTED: 2 MEDICAL CENTER REVISION SURGERY (B) (6) AFTER MRI AND BLOODWORK SHOWED ABDOMINAL INFECTION. HOSPITALIZED THIRD TIME (B)(6) WITH RECURRING INFECTION. BLOOD WORK AND ANTIBIOTICS FOR THREE DAYS." THIS FILE REPRESENTS THE PHASIX MESH.

  Patient problems: Unspecified Infection

  MAUDE report 19760965 ↗
• InjuryFeb 5, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH SEVERAL INCISIONAL HERNIAS AND INCARCERATED SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, "IDENTIFIED A LARGE VENTRAL HERNIA JUST TO LEFT OF THE UMBILICUS WHICH CONTAINED A KNUCKLE OF SMALL BOWEL AND INCARCERATED OMENTUM. THE HERNIA DEFECT WAS EXPOSED WITH SOME OMENTAL ADHESIONS. SEVERAL ADDITIONAL SMALL INCISIONAL HERNIAS WERE CONVERTED INTO ONE LARGE MIDLINE FASCIAL DEFECT AND REMOVED ALONG WITH ADHESIONS. A COMPOSIX MESH (DEVICE #1) WAS THEN CUT TO APPROPRIATE SHAPE AND SUTURED TO THE EDGES OF THE FASCIA CIRCUMFERENTIALLY USING SUTURES." ON (B)(6) 2007 - PATIENT WAS ADMITTED WITH ABDOMINAL WOUND DEHISCENCE, INFECTION AND ABDOMINAL PAIN THEREBY UNDERWENT DRAINAGE WITH WOUND VAC. ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH MESH INFECTION THEREBY UNDERWENT REPAIR WITH REMOVAL OF THE MESH (DEVICE #1). PER OPERATIVE NOTES, "THE PATIENT HAD AN OPEN WOUND WITH EXPOSED HERNIA MESH. MESH EDGES WERE IDENTIFIED AND THE MESH (DEVICE #1) WAS DISSECTED FROM SURFACE OF THE FASCIA ALONG WITH THE SUTURES. WOUND VAC WAS PLACED." ON

  Patient problems: Adhesion(s); Hernia; Seroma

  MAUDE report 18638955 ↗
• InjuryFeb 5, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH SEVERAL INCISIONAL HERNIAS AND INCARCERATED SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, "IDENTIFIED A LARGE VENTRAL HERNIA JUST TO LEFT OF THE UMBILICUS WHICH CONTAINED A KNUCKLE OF SMALL BOWEL AND INCARCERATED OMENTUM. THE HERNIA DEFECT WAS EXPOSED WITH SOME OMENTAL ADHESIONS. SEVERAL ADDITIONAL SMALL INCISIONAL HERNIAS WERE CONVERTED INTO ONE LARGE MIDLINE FASCIAL DEFECT AND REMOVED ALONG WITH ADHESIONS. A COMPOSIX MESH (DEVICE #1) WAS THEN CUT TO APPROPRIATE SHAPE AND SUTURED TO THE EDGES OF THE FASCIA CIRCUMFERENTIALLY USING SUTURES." ON (B)(6) 2007 - PATIENT WAS ADMITTED WITH ABDOMINAL WOUND DEHISCENCE, INFECTION AND ABDOMINAL PAIN THEREBY UNDERWENT DRAINAGE WITH WOUND VAC. ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH MESH INFECTION THEREBY UNDERWENT REPAIR WITH REMOVAL OF THE MESH (DEVICE #1). PER OPERATIVE NOTES, "THE PATIENT HAD AN OPEN WOUND WITH EXPOSED HERNIA MESH. MESH EDGES WERE IDENTIFIED AND THE MESH (DEVICE #1) WAS DISSECTED FROM SURFACE OF THE FASCIA ALONG WITH THE SUTURES. WOUND VAC WAS PLACED." ON

  Patient problems: Adhesion(s); Hernia; Seroma

  MAUDE report 18638952 ↗
• 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 15939066 ↗
• InjuryJun 16, 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 MESH (BARD FLAT MESH) ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT 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 14711728 ↗
• InjuryMar 30, 2022Defective 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 MESH (BARD FLAT MESH) ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). 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; Scar Tissue; Seroma; Unspecified Infection

  MAUDE report 13951715 ↗
• MalfunctionAug 24, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, ON (B)(6) 2021, A TEAR WAS NOTED IN THE INNER MESH POUCH WHILE OPENING THE FULLY SEALED OUTER PACKAGE OF A BARD/DAVOL PHASIX MESH. IT WAS REPORTED THAT THE MESH WAS NOT USED AND ANOTHER PHASIX MESH WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE OUTER PRODUCT BOX HAD INTACT SEALS PRIOR TO OPENING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358510 ↗
• InjuryJul 1, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2010, VENTRALEX ST AND VENTRIO ST ON (B)(6) 2014, PHASIX MESH AND XENMATRIX AB ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2016. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, ¿THE LIPOMA OF THE CORD WAS EXCISED. A SEPRAMESH IP (DEVICE #1) WAS PLACED AND SECURED TO THE FASCIA USING SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT COMPLEX VENTRAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE #1) AND IMPLANT

  Patient problems: Abdominal Pain; Abscess; Insufficient Information; Pain

  MAUDE report 12097830 ↗
• 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: Adhesion(s); Hernia; Inflammation; Insufficient Information; Necrosis; Pain

  MAUDE report 11900588 ↗
• 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 11900586 ↗
• InjuryOct 7, 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 VENTRALIGHT ST, VENTRIO ST AND PHASIX ON (B)(6) 2015 (X2) AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST AND PHASIX. 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; Obstruction/Occlusion

  MAUDE report 10641563 ↗
• InjuryAug 26, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A NON-BARD DAVOL MESH TO REPAIR AN UMBILICAL HERNIA. ON OR ABOUT (B)(6) 2015, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY; A BARD/DAVOL VENTRALIGHT ST W/ECHO POSITIONING SYSTEM WAS IMPLANTED IN AN ATTEMPT TO REPAIR THE RECURRENT VENTRAL HERNIA DEFECT. UPON ENTERING THE ABDOMEN, THE SURGEON NOTED THERE WAS A RECURRENT HERNIA DEFECT WITH INCARCERATED OMENTUM. ADHESIONS WERE TAKEN DOWN. ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT SURGERY TO REMOVE THE INFECTED MESH AND A BARD/DAVOL PHASIX WAS IMPLANTED IN AN ATTEMPT TO REPAIR THE RECURRENT VENTRAL HERNIAS. UPON ENTERING THE ABDOMEN, THE SURGEON NOTED THE PRESENCE OF A COMPLEX PARTIAL BOWEL OBSTRUCTION. THE MESH HAD BECOME MATTED TO THE SMALL BOWEL AND OMENTUM. EXTENSIVE ADHESIONS WERE LYSED AND THE COMPLEX PARTIAL SMALL BOWEL OBSTRUCTION WAS RELEASED. THE INFECTED MESH WAS REMOVED. IT IS ALLEGED THAT THE MESH PRODUCTS CAUSED SERIOUS INJURY AND HAD TO BE REMOVED VIA INVASIVE SURGERY. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE PAIN, INFLAMMATION, NAUSEA, VOMITING, DIARRHEA, CHILLS, LOSS OF APPETITE, SEVERE PAIN AND SUFFERIN

  Patient problems: Disability; Inflammation; Pain

  MAUDE report 10456825 ↗
• InjuryJan 14, 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 AND OBSTRUCTION. ON (B)(6) 2015 THE SUBJECT PATIENT UNDERWENT REPAIR OF A PRIMARY MIDLINE INCISIONAL HERNIA UTILIZING THE PHASIX MESH. A RETRO-RECTUS WITHOUT COMPONENT SEPARATION APPROACH WITH RIVES-STOPPA TECHNIQUE WAS USED. THE LENGTH OF THE SWISS CHEESE DEFECT MEASURED 14 CM X 10 CM. PERIMETER FIXATION WAS PERFORMED WITH ABSORBABLE MONOFILAMENT SUTURE. ELEVEN (11) POINTS OF FIXATION WERE MADE. THE FASCIA WAS RE-APPROXIMATED AND THE SKIN WAS FULLY CLOSED. ON (B)(6) 2019 THE PATIENT WAS DIAGNOSED WITH A SMALL BOWEL OBSTRUCTION AND PARASTOMAL HERNIA RECURRENCE. THE PATIENT WAS TREATED WITH A NASOGASTRIC TUBE AND THE OBSTRUCTION RESOLVED ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT UNDERWENT LAPAROSCOPIC PARASTOMAL HERNIA REPAIR. THE HERNIA MEASURED 4 CM BY 4CM. THERE WAS NO NOTED SWISS CHEESE CONFIGURATION. THE PHASIX MESH WAS NOT EXPLANTED AT THIS TIME AND THE FASCIA WAS RE-APPROXIMATED AND THE SKIN FULLY CLOSED. THE ADVERSE EVENTS WERE ASSESSED PER THE CLINICIAN AS POSSIBLE RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE BOWEL OBSTRUCTION AND RECURR

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 9588478 ↗
• InjuryJan 14, 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) 2015 THE SUBJECT PATIENT UNDERWENT AN OPEN REPAIR OF A MIDLINE INCISIONAL HERNIA USING THE PHASIX MESH. A RETRO-RECTUS PLACEMENT WITH COMPONENT SEPARATION POSTERIOR TECHNIQUE WAS UTILIZED. THE LENGTH OF THE SWISS CHEESE LIKE DEFECT MEASURED 14 CM AND THE WIDTH MEASURED 9 CM. PERIMETER FIXATION WAS PERFORMED WITH ABSORBABLE MONOFILAMENT SUTURE. TWELVE (12) POINTS OF FIXATION WERE MADE. THE WOUND AND FASCIA WERE CLOSED. SKIN WAS FULLY CLOSED. ON (B)(6) 2017 THE SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENCE HERNIA (8 X 8CM) IN THE SAME LOCATION WITH A CT SCAN PERFORMED. ON (B)(6) 2017 THE PATIENT UNDERWENT ADDITIONAL SURGERY TO REPAIR THE RECURRENT HERNIA. A PRIMARY REPAIR WAS PERFORMED. THE RECURRENT HERNIA HAS BEEN ASSESSED PER THE STUDY CLINICIAN AS POSSIBLE RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE CLINICIAN HAS ASSESSED THE RECURRENCE AS A SERIOUS ADVERSE EVENT OF MODERATE SEVERITY.

  Patient problems: Hernia

  MAUDE report 9588218 ↗
• 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. AS REPORTED PER PHASIX CLINICAL STUDY DVL-HE-011: ON (B)(6) 2014 THE SUBJECT PATIENT UNDERWENT REPAIR OF A PRIMARY VENTRAL HERNIA UTILIZING BARD PHASIX MESH. AN ONLAY PLACEMENT WITH COMPONENT SEPARATION, RAMIREZ/OPEN TECHNIQUE WAS PERFORMED. THE LENGTH OF THE DEFECT MEASURED 24CM AND MEASURED 15CM IN WIDTH. IN ADDITION TO THIS PROCEDURE, LYSIS OF ADHESIONS AND A TAKEDOWN OF ILEOSTOMY WITH ILEOCOLONIC ANASTOMOSIS WAS PERFORMED. THE METHOD OF PERIMETER FIXATION WAS ABSORBABLE MONOFILAMENT SUTURE WITH 20 FIXATION POINTS. THE FASCIA WAS RE-APPROXIMATED AND THE SKIN WAS FULLY CLOSED. ON (B)(6) 2017 THE SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENT HERNIA. THE ADVERSE EVENT HAS BEEN ASSESSED PER THE CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED AS MILD IN SEVERITY, NOT SERIOUS WITH AN ONGOING RESOLUTION DATE. NO ACTION HAS BEEN TAKEN.

  Patient problems: Hernia

  MAUDE report 9574819 ↗
• InjuryJan 9, 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) 2015 THE SUBJECT PATIENT UNDERWENT AN OPEN REPAIR OF A FIRST TIME RECURRENT MIDLINE INCISIONAL HERNIA USING THE PHASIX MESH. A RETRO-RECTUS PLACEMENT WITH COMPONENT SEPARATION RAMIREZ TECHNIQUE WAS UTILIZED. THE LENGTH OF THE SWISS CHEESE LIKE DEFECT MEASURED 8 CM AND THE WIDTH MEASURED 18 CM. PERIMETER FIXATION WAS PERFORMED WITH ABSORBABLE MONOFILAMENT SUTURE. EIGHT (8) POINTS OF FIXATION WERE MADE. THE WOUND AND FASCIA WERE CLOSED, THE SKIN WAS FULLY CLOSED. ON (B)(6) 2017 THE SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENT HERNIA (7 X 7 CM) IN THE SAME LOCATION. ON (B)(6) 2017 THE SUBJECT PATIENT UNDERWENT ADDITIONAL SURGERY TO REPAIR THE RECURRENT HERNIA. A PRIMARY REPAIR WAS PERFORMED. THIS RECURRENT HERNIA HAS BEEN ASSESSED PER THE STUDY CLINICIAN AS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE CLINICIAN HAS ASSESSED THE RECURRENCE AS A SERIOUS ADVERSE EVENT OF MODERATE SEVERITY.

  Patient problems: Hernia

  MAUDE report 9571993 ↗
• InjurySep 12, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED ON (B)(6) 2019 A PATIENT THAT HAD MULTIPLE DEFECTS AND QUESTIONABLE TISSUE (POSTERIOR SHEATH) UNDERWENT A RETRO RECTUS REPAIR WITH PST AND ON-LAY WITH BARD PHASIX FLAT MESH. THREE WEEKS POSTOPERATIVELY THE PATIENT DEVELOPED A WOUND INFECTION FOR WHICH A WOUND VAC WAS PLACED, ALSO NOTED WAS EXPOSED MESH. APPROXIMATELY TWO WEEKS LATER THE PATIENT UNDERWENT WASHOUT AND REMOVAL OF DEAD SUBCUTANEOUS TISSUE. IT WAS NOTED THAT "THE MESH WAS AT LEAST 90% INCORPORATED AND THE SURGEON WAS MORE THAN PLEASED AND RATHER IMPRESSED." AS OF (B)(6) 2019 THE SURGEON REPORTS "THE PATIENT¿S WHITE BLOOD CELL COUNT HAD GONE BACK DOWN TO NORMAL FROM ANTIBIOTICS AND WASHOUTS AND THE PHASIX MESH IS MORE INCORPORATED THAN I HAD EVER HOPED." AS REPORTED THE PATIENT IS OBESE WITH A HIGH BMI, IS ADDICTED TO NARCOTICS, AND IS A CHRONIC SMOKER AND AS REPORTED THE SURGEON "BELIEVED THE TISSUE WAS DYING DUE TO THE PATIENT¿S CONTINUED SMOKING AND POOR VASCULARIZATION TO THE SUBCUTANEOUS TISSUE." HIS PLAN FOLLOWING IS TO KEEP AN EYE ON THE REMAINING TISSUE STAYING HEALTHY, THEN SKIN GRAFT AND CLOSE THE WOUND LATER ON.

  Patient problems: Impaired Healing; Necrosis; Unspecified Infection

  MAUDE report 9005600 ↗
• InjuryAug 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO IS PART OF A CLINICAL STUDY ((B)(6)) EXPERIENCED A HERNIA RECURRENCE ON (B)(6) 2016 - THE SUBJECT PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR WITH PHASIX MESH UTILIZING ONLAY PLACEMENT WITH COMPONENT SEPARATION, POSTERIOR TECHNIQUE, A PANNICULECTOMY AND LYSIS OF ADHESIONS. ALSO PERFORMED AT THIS TIME WAS AN ILEO-RECTAL ANASTOMOSIS, AND LOOP ILEOSTOMY. THE FASCIA AND SKIN OF THE WOUND WERE FULLY CLOSED. A URINARY BLADDER PERFORATION OCCURRED DURING THIS PROCEDURE, WHICH WAS REPAIRED, AND A URINARY CATHETER WAS PLACED. ON (B)(6) 2016 - THE SUBJECT PATIENT EXPERIENCED A SEVERE PULMONARY EMBOLISM. PER THE INFORMATION PROVIDED "PATIENT WAS IMMOBILIZED POST OP AND HE IS RELATIVELY OBESE HE HAD ALSO JUST HAD A HUGE OPERATION. THESE RISK FACTORS PREDISPOSE HIM TO A PE (PULMONARY EMBOLISM)." THE CLINICIAN REPORTED THE PE WAS UNRELATED TO THE DEVICE USED TO TREAT THE HERNIA. ON (B)(6) 2018 - THE SUBJECT PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE. THE HERNIA RECURRENCE WAS DETECTED AT REFERRING HOSPITAL WHILE PATIENT WAS BEING CARED FOR THERE. THIS ALLEGED RECURRENCE WILL BE VERIFIED DURING THE PATIENT'S TWO YEAR FOLLOW UP. THE RECURRENCE IS ASSESSED B

  Patient problems: Hernia

  MAUDE report 7822462 ↗
• InjuryJun 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING IS ASSOCIATED WITH A PATIENT WHO IS PART OF A CLINICAL STUDY: ON (B)(6) 2017 - THE PATIENT UNDERWENT THE REPAIR OF A PRIMARY INCISIONAL MIDLINE HERNIA WITH MULTIPLE MIDLINE DEFECTS AND WAS IMPLANTED WITH A PHASIX MESH. A RETRO-RECTUS WITH COMPONENT SEPARATION TECHNIQUE (POSTERIOR TECHNIQUE) WAS PERFORMED. THE HERNIA DEFECT MEASURED 14CM IN LENGTH AND 4CM IN WIDTH WITH SWISS CHEESE CONFIGURATION AND MULTIPLE DISCREET HERNIAS. THE HERNIA SITE WAS ASSESSED AS CLEAN CONTAMINATED AND CLASSIFIED AS VHWG GRADE 3 DUE TO TAKE DOWN OF ILEOSTOMY WITH ILEOCOLONIC ANASTOMOSIS AND CREATED OF A STOMA. THE MESH WAS FIXATED WITH 6 FIXATION POINTS USING MECHANICAL FIXATION. ON (B)(6) 2018 - THE PATIENT WAS DIAGNOSED WITH CHRONIC INFLAMMATION AND FASCIITIS ON THE UNDERLYING MESH. THIS AE HAS BEEN ASSESSED BY THE CLINICIAN AS MILD IN SEVERITY, POSSIBLY RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE PATIENT WAS SENT FOR A CT SCAN OF THE ABDOMEN AND A CONSULTATION WITH A PAIN THERAPIST. THIS CONDITION IS ONGOING AND WILL BE RE-EVALUATED AT A LATER DATE BY THE CLINICIAN.

  Patient problems: Fasciitis; Inflammation; Pain

  MAUDE report 7581731 ↗