Phasix 1190200Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741077678), received between May 28, 2019 and Jul 28, 2026 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (14 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2017 - Patient was diagnosed with left and right inguinal hernias and umbilical and incarcerated ventral hernias thereby underwent laparoscopic and open repair with implant of 3DMax (Device 1 and 2) and synthetic mesh. Per op notes, "On the left inguinal region, a large direct hernia was identified and reduced. An indirect hernia was identified and reduced. A 3DMax (Device 1 - left) was placed and tacked. On the right inguinal region, A direct and indirect hernia sacs were identified and reduced. A 3DMax (Device 2 - right) was placed and tacked. Periumbilical defect and umbilical defect were noted with incarcerated omentum were reduced. A synthetic mesh was placed and sutured."(b)(6) 2017 - Patient was diagnosed with infection and inflammatory reaction due to prosthetic device in the abdominal wall thereby provided with Antibiotics. (b)(6) 2017 - Patient was diagnosed with chronic abdominal wall wound infection with mesh thereby underwent open repair with excision of synthetic mesh. Per op notes, "Sinus draining was opened and drained. Dissection carried to the fascia and identified the synthetic mesh. The synthetic mesh was removed. The fascia was c

  Patient problems: Abdominal Pain

  MAUDE report 50050314 ↗
• InjuryNov 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE PERITONEAL CAVITY. HERNIA SAC WAS DISSECTED OUT. A SEPRAMESH IP (DEVICE 1) WAS PLACED INTO THE ABDOMINAL CAVITY AND SECURE IT WITH SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA, PAIN, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE 1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE RIGHT LOWER ABDOMEN. HERNIA SAC WAS DISSECTED OUT. THERE WAS DENSE ADHESION INTO THE ABDOMEN, WHICH WAS REMOVED ENTIRELY. PREVIOUSLY PLACED SEPRAMESH IP (DEVICE 1) WAS CRUMPLED AND THAT WAS REMOVED ENTIRELY. A SYNTHETIC MESH WAS PLACED INTO THE DEFECT AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA, ADHESION, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 2) AND PHASIX FLAT MESH (DEVICE 3). PER OPERATIVE NOTES, ¿A LOWER ABDOMEN VENTRAL HERNIA SAC WAS IDENTIFIED. HERNIA SAC WAS EXCISED FROM ABDOMEN. LYSIS OF ADHESION WA

  Patient problems: Necrosis; Wound Dehiscence

  MAUDE report 23665076 ↗
• InjuryOct 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED OUT. A SMALL PIECE OF COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED AGAINST THE POSTERIOR SURFACE OF THE ANTERIOR ABDOMINAL WALL AND SUTURED.¿ ON (B)(6) 2015 ¿ PATIENT HAD ABDOMINAL CELLULITIS WITH POSSIBLE MRSA THEREBY UNDERWENT RESECTION OF CHRONICALLY INFECTED ABDOMINAL WALL INTRAPERITONEAL MESH (DEVICE 1) AND PRIMARY CLOSURE OF FASCIAL DEFECT. THE COMPOSIX KUGEL MESH (DEVICE 1) WAS REMOVED.¿ (NOTE: THERE IS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RIGHT UPPER QUADRANT PAIN AND RECURRENT VENTRAL ABDOMINAL WALL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS EXCISED. SCARRING WAS NOTED. A VENTRALEX ST MESH (DEVICE 2) WAS PLACED INTO THE PERITONEAL CAVITY AND SECURED TO THE FASCIA USING SUTURES.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RIGHT INDIRECT INGUINAL HERNIA AND SMALL DIRECT INGUINA

  Patient problems: Hernia; Neuralgia; Scar Tissue

  MAUDE report 23345571 ↗
• MalfunctionAug 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A ROBOTIC TAPP PROCEDURE WITH A PHASIX MESH ON (B)(6) 2025. THREE DAYS POST IMPLANT THE PATIENT DEVELOPED A RASH IN THE ABDOMINAL AND LEG AREA AND HAS SINCE VISITED THE EMERGENCY ROOM MULTIPLE TIMES. THE PATIENT WAS GIVEN STEROIDS FOR THE RASH WHICH HELPED IMPROVE THE RASH TO SOME EXTENT, BUT THE RASH CAME BACK. THE PATIENT HAS NO OTHER SYMPTOMS. THE PATIENT HAS BEEN PRESCRIBED STEROIDS AND ANTIHISTAMINES, NO OTHER TREATMENT PLAN AT THIS TIME.

  Patient problems: Rash

  MAUDE report 22917474 ↗
• InjuryJun 10, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH LEFT LARGE INCARCERATED INCISIONAL HERNIA AND RECURRENT INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST (DEVICE #1) AND PHASIX MESH (DEVICE #2) FOR OPEN LEFT FLANK REPAIR AND VENTRALEX ST (DEVICE #3) FOR OPEN UMBILICAL REPAIR. PER OPERATIVE NOTES, "ON LEFT FLANK, A LARGE HERNIA DEFECT WAS NOTED. A VENTRAL MESH WAS PLACED IN CIRCUMFERENTIAL FASHION, ANOTHER MESH (VENTRIO ST - DEVICE #1, PHASIX MESH - DEVICE #2) WAS PLACED AND SUTURED. ON UMBILICAL AREA, THE HERNIA DEFECT WAS NOTED AND REDUCED. A VENTRALEX ST (DEVICE #3) WAS PLACED AND SUTURED." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE # 1, #2) AND IMPLANT OF PHASIX ST MESH (DEVICE #4). PER OPERATIVE NOTES, "THE PREVIOUSLY PLACED MESH WAS FRACTURED AND RUPTURED TO THE EXTERNAL OBLIQUE. THE MESH WAS REMOVED. A PHASIX ST MESH (DEVICE #4) WAS SECURED WITH SUTURES IN A ONLAY FASHION. ANOTHER PIECE OF MESH (DEVICE #4) WAS SECURED AND SUTURED." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA WITH INCARCERAT

  Patient problems: Hernia

  MAUDE report 22177093 ↗
• InjuryJun 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA SAC WAS REMOVED. A VENTRIO ST MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INFECTED MESH AND ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE #2) AND REMOVAL OF MESH (DEVICE #1). PER OPERATIVE NOTES, "THE MESH (DEVICE #1) WAS REMOVED. A PHASIX MESH (DEVICE #2) WAS PLACED IN A OVERLAY REINFORCEMENT OF PRIMARY CLOSURE AND TACKED." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RIGHT COSTAL MARGIN ABSCESS THEREBY UNDERWENT DRAINAGE OF ABSCESS, PURULENT DISCHARGE AND REMOVAL OF MESH (DEVICE #2). PER OPERATIVE NOTES, "A SMALL FLUID COLLECTION WAS ENCOUNTERED, PROLENE SUTURES WERE IDENTIFIED AND REMOVED. THE PHASIX MESH WAS REMOVED." (B)(6) 2016 - PATIENT UNDERWENT ABDOMINAL SCAR REVISION, REMOVAL OF SUTURE GRANULOMA AND CLOSURE OF WOUND.

  Patient problems: Abscess; Drug Resistant Bacterial Infection; Purulent Discharge

  MAUDE report 22160606 ↗
• InjuryApr 30, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER PLAINTIFF PROFILE FORM ((B)(6)): 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 WI

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

  MAUDE report 21938254 ↗
• InjuryApr 22, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS EXCISED. A VENTRIO ST MESH (DEVICE #1) WAS PLACED INTO THE ABDOMEN AND SUTURED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA AND EXPLORATORY LAPAROTOMY THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF OLD MESH (DEVICE #1) AND IMPLANT OF PHASIX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE FASCIA WAS CLOSED UNDER THE SEROMA, GRASPED THE VENTRIO ST MESH (DEVICE #1) AND WERE ABLE TO PULL AWAY FROM THE ANTERIOR ABDOMINAL WALL. THE SEROMA WAS ENTIRELY DRAINED, AND THE MESH WAS REMOVED. ADHESIONS WERE TAKEN DOWN. A PHASIX MESH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ABSCESS & SEPSIS, OPEN WOUND ABDOMINAL WALL THEREBY UNDERWENT EXCISION & DEBRIDEMENT OF SKIN AND SUBCUTANEOUS TISSUE TO FASCIA. PER OPERATIVE NOTES, ¿INCISING THE SKIN AND SUBCUTANEOUS TISSUE OVERLYING THE OPEN DRAINING WOUND AND AREA OF CELLULITIS. ALL CHRONICALLY INFLAMED TISSUE WAS REMOVED.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHE

  Patient problems: Abscess; Cellulitis; Inflammation; Sepsis

  MAUDE report 21879726 ↗
• InjuryFeb 20, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH DIRECT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿AN INDIRECT SAC WAS SEEN AND CORD LIPOMA WAS DISSECTED FREE. THE LARGE DIRECT DEFECT WAS NOTED. THE LARGE PERFIX PLUG (DEVICE #1) WAS PLACED INTO THE DEFECT, SECURED WITH INTERRUPTED SUTURES. THE ONLAY PATCH WAS THEN PLACED INTO THE CANAL, SECURED IN ALL DIRECTIONS WITH THE INTERRUPTED SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LEFT ILIOINGUINAL NERVE ENTRAPMENT THEREBY UNDERWENT REPAIR WITH PARTIAL REMOVAL OF MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE EDGES OF THE MESH WERE DISSECTED OUT LATERALLY AND SUPERIORLY. ILIOINGUINAL NERVE INTO THE AREA AND SOME OTHER FIBROUS BANDS WERE DIVIDED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH CHRONIC LEFT GROIN PAIN THEREBY UNDERWENT REPAIR. PER OPERATIVE NOTES, ¿FLAP WAS CREATED SUPERIORLY AND THEN INFERIORLY FREED UP THE CORD AND MESH (DEVICE #1) THROUGH CONSIDERABLE SCAR TISSUE TO THE INFERIOR EDGE OF THE MESH. THE MESH (DEVICE #1) WAS INTACT. THE TAILS OF PREVIOUSLY PLACED MESH HAD SEPARATED AND THERE WAS A SMALL DEFECT LATERAL TO THE INTERNAL

  Patient problems: Ischemia; Necrosis; Pain

  MAUDE report 21419209 ↗
• InjuryJan 28, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION SECONDARY TO INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA SAC WAS DISSECTED FREE BACK TO FASCIA. THE SAC WAS VERY THICK WALLED OF THE FAT IN THE PREPERITONEAL SPACE. THE BOWEL WAS THEN REDUCED. A COMPOSIX E/X MESH (DEVICE #1) WAS PLACED IN THE INTRAPERITONEAL SPACE WITH PTFE SIDE TOWARD BOWEL AND SUTURED. THEN THE DEFECT WAS CLOSED OVER THIS MESH." ON (B)(6) 2016 - PATIENT VISITED HOSPITAL FOR ABDOMINAL WALL CELLULITIS THEREBY PROVIDED WITH MEDICATION. ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA AND VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH EXPLANT OF COMPOSIX E/X MESH (DEVICE #1), IMPLANT OF PHASIX MESH (DEVICE #2) AND DRAINAGE OF INTRAABDOMINAL ABSCESS. PER OPERATIVE NOTES, "THE AREA OF FISTULA IN THE MID ABDOMEN WITH LARGE AMOUNT OF ADHESIONS WERE NOTED. THE MESH WAS ADHESED TO THE BOWEL WITH LARGE OPENING CONSISTENT WITH AREA OF FISTULA, UNDERNEATH OF THE MESH LARGE POCKET OF ABSCESS AND PUS NOTED WHICH WAS DEB

  Patient problems: Abscess; Drug Resistant Bacterial Infection; Fistula; Hematoma; Necrosis; Sepsis

  MAUDE report 21252813 ↗
• InjurySep 4, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT EXPERIENCED ABDOMINAL ADHESION, SCAR TISSUE AND BULGE AROUND BELLY BUTTON POST IMPLANT OF PHASIX FLAT MESH. THE PATIENT UNDERWENT REVISION SURGERY IN ATTEMPT TO RELEASE THE SCAR TISSUE AND THE BULGE AROUND BELLY BUTTON DID NOT RESOLVE. IT WAS STATED THAT THE DISSOLVABLE MESH WAS NOT REMOVED, AND THE SURGEON DOES NOT FEEL COMFORTABLE FIXING THE ADHESION.

  Patient problems: Adhesion(s); Scar Tissue

  MAUDE report 20135446 ↗
• InjuryOct 26, 2023Inadequate Instructions for Healthcare Professional; Improper or Incorrect Procedure or Method; Inadequate Instructions for Healthcare Professional; Improper or Incorrect Procedure or Method

  AS PER MEDWATCH FORM, "INCOMPATIBLE MESH WAS PLACED IN PATIENT. PATIENT WAS BROUGHT BACK TO SURGERY HOURS LATER TO REPLACE WITH A MESH THAT COULD BE PLACED ADJACENT TO THE BOWEL. THERE WERE NO COMPLICATIONS REPLACING THE MESH. IT WAS DISCOVERED THE INITIAL MESH PLACED COULD NOT BE PLACED NEXT TO THE BOWEL. DURING OUR EVENT REVIEW WE DISCOVERED THAT THE MESH PRODUCTS HAVE NEARLY THE SAME NAME AND PACKAGING. PHASIX AND PHASIX ST. THERE IS NO DESCRIPTION ON THE MESH PACKAGE LABEL THAT INDICATES IF ONE OR THE OTHER PRODUCT CAN OR CANNOT BE PLACED NEXT TO THE BOWEL. BOTH PRODUCTS ARE BIOLOGICS. THE PRODUCT REP KNEW WHICH MESH COULD BE PLACED BY THE BOWEL. HOWEVER WE COULD NOT QUICKLY REACH THE PRODUCT REP THROUGH THE COMPANY WEBSITE PHONE NUMBERS. IT TOOK SEVERAL PHONE CALLS AND TRANSFERS. SECOND, THE INSTRUCTIONS INSIDE THE PACKAGE DO INDICATE WHETHER OR NOT THE MESH CAN BE PLACED NEXT TO THE BOWEL. HOWEVER, THIS INSTRUCTION IS INSIDE A PRODUCT THAT IS MANY THOUSANDS OF DOLLARS AND THE TEAM DIDN'T WANT TO WASTE AN EXPENSIVE PRODUCT BY OPENING IT. WE LATER DISCOVERED THE OUTER PACKAGE CAN BE OPENED FOR THE INSTRUCTIONS WITHOUT COMPROMISING THE INTEGRITY OF THE MESH PRODUCT. OUR REQUEST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014107 ↗
• InjurySep 22, 2023Migration or Expulsion of Device; Defective Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION, INCARCERATED VENTRAL INCISIONAL HERNIA, AND UNDERWENT LAPAROSCOPIC ASSISTED OPEN REPAIR WITH THE IMPLANT OF SEPRAMESH IP. PER OPERATIVE NOTES, ¿THERE WAS 2 TO 3 SEPARATE LOOPS OF BOWEL ADHERENT WITHIN HERNIA DEFECT. A SEPRAMESH IP (DEVICE #1) WAS PLACED WITHIN THE PERITONEAL CAVITY AND TACKED.¿ 09-FEB-2011 TO 09-FEB-2014 - PATIENT HAD RIGHT UPPER QUADRANT AND LEFT LOWER QUADRANT ABDOMINAL PAIN, MASS IN LEFT SIDE ABDOMEN, ABDOMINAL WALL ABSCESS, INFECTION. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH LEFT ABDOMINAL WALL ABSCESS THEREBY UNDERWENT EXCISION WITH INCISION AND DRAINAGE. PER OPERATIVE NOTES, ¿AN ELLIPTICAL RESECTION OF THE ANTERIOR WALL WAS COMPLETED. ENTRY INTO THE ABSCESS DID CONFIRM CLASSIC NONMALODOROUS PURULENCE. THE ANTERIOR WALL WAS EXCISED. THE ABSCESS WAS ASPIRATED, AND THE CAVITY WAS PACKED. THERE WAS ABSOLUTELY NO SUGGESTION OF ANY MESH OR OTHER FOREIGN BODY PRESENT.¿ 14-FEB-2014 TO 11-NOV-2015 - PATIENT FREQUENTLY VISITED HOSPITAL FOR PAIN, ABDOMINAL WOUND HEALING AND MASS. PATIENT HAD PURULENT DRAINAGE AND MESH WITH ABDOMINAL WALL INFECTION. (B)(6) 20

  Patient problems: Abdominal Pain; Unspecified Infection

  MAUDE report 17799401 ↗
• InjuryMay 25, 2023Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED COMPOSIX KUGEL HERNIA PATCH ON (B)(6)2012 AND (B)(6)2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6)2019,(B)(6)2020,(B)(6)2020,(B)(6)2020 AND (B)(6)2021. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Adhesion(s); Fistula; Hernia; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 17000952 ↗
• InjuryJun 22, 2021Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL PHASIX MESH ON (B)(6) 2015 AND VENTRALIGHT ST ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 12042738 ↗
• InjurySep 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A PHASIX 4X6 IN (10X15CM) MESH USING DIEP (DEEP INFERIOR EPIGASTRIC PERFORATORS) PROCEDURE IN THE ABDOMEN, WHERE AN INCISION WAS MADE, NATURAL TISSUE WAS REMOVED AND MUSCLE WAS DISRUPTED. THE MESH WAS NOT PLACED AS AN ONLAY BUT DEEP IN THE FACIA TO REINFORCE THE AREA OF DISRUPTION, TO PREVENT BULGE AND FOR TISSUE REINFORCEMENT. IT WAS REPORTED THE ISSUE OCCURRED AROUND 6-12 WEEKS POST OPERATION, THE PATIENT DEVELOPED TUNNELING SINUS TRACTS TO THE MESH, THE WOUND DEHISCED AND HAD SURGICAL INTERVENTION WHERE THE MESH WAS REMOVED. THE CULTURE WAS POSITIVE FOR BACTERIA.

  Patient problems: Bacterial Infection; Unspecified Infection; Wound Dehiscence

  MAUDE report 10606653 ↗
• InjurySep 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A PHASIX 4 X 6 IN (10 X 15CM) MESH USING DIEP (DEEP INFERIOR EPIGASTRIC PERFORATORS) PROCEDURE IN THE ABDOMEN, WHERE AN INCISION WAS MADE, NATURAL TISSUE WAS REMOVED AND MUSCLE WAS DISRUPTED. THE MESH WAS NOT PLACED AS AN ONLAY BUT DEEP IN THE FACIA TO REINFORCE THE AREA OF DISRUPTION, TO PREVENT BULGE AND FOR TISSUE REINFORCEMENT. IT WAS REPORTED THE ISSUE OCCURRED AROUND 6-12 WEEKS POST OPERATION, THE PATIENT DEVELOPED TUNNELING SINUS TRACTS TO THE MESH, THE WOUND DEHISCED AND HAD SURGICAL INTERVENTION WHERE THE MESH WAS REMOVED. THE CULTURE WAS POSITIVE FOR BACTERIA.

  Patient problems: Bacterial Infection; Unspecified Infection; Wound Dehiscence

  MAUDE report 10606652 ↗
• InjurySep 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A PHASIX 4X6 IN (10X15CM) MESH USING DIEP (DEEP INFERIOR EPIGASTRIC PERFORATORS) PROCEDURE IN THE ABDOMEN, WHERE AN INCISION WAS MADE, NATURAL TISSUE WAS REMOVED AND MUSCLE WAS DISRUPTED. THE MESH WAS NOT PLACED AS AN ONLAY BUT DEEP IN THE FACIA TO REINFORCE THE AREA OF DISRUPTION, TO PREVENT BULGE AND FOR TISSUE REINFORCEMENT. IT WAS REPORTED THE ISSUE OCCURRED AROUND 6-12 WEEKS POST OPERATION, THE PATIENT DEVELOPED TUNNELING SINUS TRACTS TO THE MESH, THE WOUND DEHISCED AND HAD SURGICAL INTERVENTION WHERE THE MESH WAS REMOVED. THE CULTURE WAS POSITIVE FOR MYCOBACTERIUM FORTUITUM.

  Patient problems: Bacterial Infection; Unspecified Infection; Wound Dehiscence

  MAUDE report 10606648 ↗
• InjurySep 30, 2020No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A PHASIX 4X6 IN (10X15CM) MESH USING DIEP (DEEP INFERIOR EPIGASTRIC PERFORATORS) PROCEDURE IN THE ABDOMEN, WHERE AN INCISION WAS MADE, NATURAL TISSUE WAS REMOVED AND MUSCLE WAS DISRUPTED. THE MESH WAS NOT PLACED AS AN ONLAY BUT DEEP IN THE FACIA TO REINFORCE THE AREA OF DISRUPTION, TO PREVENT BULGE AND FOR TISSUE REINFORCEMENT. IT WAS REPORTED THE ISSUE OCCURRED AROUND 6-12 WEEKS POST OPERATION, THE PATIENT DEVELOPED TUNNELING SINUS TRACTS TO THE MESH, THE WOUND DEHISCED AND HAD SURGICAL INTERVENTION WHERE THE MESH WAS REMOVED. THE CULTURE WAS POSITIVE FOR BACTERIA.

  Patient problems: Bacterial Infection; Not Applicable; Unspecified Infection; Wound Dehiscence

  MAUDE report 10606646 ↗
• InjurySep 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A PHASIX 4X6 IN (10X15CM) MESH USING DIEP (DEEP INFERIOR EPIGASTRIC PERFORATORS) PROCEDURE IN THE ABDOMEN, WHERE AN INCISION WAS MADE, NATURAL TISSUE WAS REMOVED AND MUSCLE WAS DISRUPTED. THE MESH WAS NOT PLACED AS AN ONLAY BUT DEEP IN THE FACIA TO REINFORCE THE AREA OF DISRUPTION, TO PREVENT BULGE AND FOR TISSUE REINFORCEMENT. IT WAS REPORTED THE ISSUE OCCURRED AROUND 6-12 WEEKS POST OPERATION, THE PATIENT DEVELOPED TUNNELING SINUS TRACTS TO THE MESH, THE WOUND DEHISCED AND HAD SURGICAL INTERVENTION WHERE THE MESH WAS REMOVED. THE CULTURE WAS POSITIVE FOR BACTERIA.

  Patient problems: Bacterial Infection; Unspecified Infection; Wound Dehiscence

  MAUDE report 10606645 ↗
• InjurySep 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A PHASIX 4X6 IN (10X15CM) MESH USING DIEP (DEEP INFERIOR EPIGASTRIC PERFORATORS) PROCEDURE IN THE ABDOMEN, WHERE AN INCISION WAS MADE, NATURAL TISSUE WAS REMOVED AND MUSCLE WAS DISRUPTED. THE MESH WAS NOT PLACED AS AN ONLAY BUT DEEP IN THE FACIA TO REINFORCE THE AREA OF DISRUPTION, TO PREVENT BULGE AND FOR TISSUE REINFORCEMENT. IT WAS REPORTED THE ISSUE OCCURRED AROUND 6-12 WEEKS POST OPERATION, THE PATIENT DEVELOPED TUNNELING SINUS TRACTS TO THE MESH, THE WOUND DEHISCED AND HAD SURGICAL INTERVENTION WHERE THE MESH WAS REMOVED. THE CULTURE WAS POSITIVE FOR BACTERIA.

  Patient problems: Bacterial Infection; Unspecified Infection; Wound Dehiscence

  MAUDE report 10606644 ↗
• InjuryMay 28, 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 VENTRALIGHT ST (DEVICE #1) AND PHASIX (DEVICE #2) ON (B)(6) 2013 OR (B)(6) 2018. 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 VENTRALIGHT ST (DEVICE #1) AND PHASIX (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury; Scar Tissue; Seroma

  MAUDE report 8647563 ↗