Phasix 1201015Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741095344), received between Sep 7, 2018 and Sep 21, 2026 — classified as 13 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Patient-Device Incompatibility

  Per information provided: (b)(6)2016 - Patient was diagnosed with incisional hernia thereby underwent open repair with implant of Ventralex ST Mesh (Device 1). Per op notes, "A hernia sac in abdominal region was identified and was dissected. A Ventralex ST Mesh (Device 1) was placed into the area and sutured." (b)(6)2016 - Patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with implant ofVentralex ST Mesh (Device 2). Per op notes, "A small incision was made through the prior incision site. Hernia defect was identified and dissected. A Ventralex ST Mesh (Device 2) was placed and sutured." (b)(6)2017 - Patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with implant of Phasix ST Mesh (Device 3), Phasix Flat Mesh (Device 4). Per op notes, "Through prior incision site, the mesh (Device 1 and 2) was noted and was found adherent to the abdominal contents. The Ventralex ST Mesh (Device 2) was removed. A Phasix ST Mesh (Device 3) was placed into the defect as an underlay and was sutured. A Phasix Flat Mesh (Device 4) was placed as an onlay and was sutured." (b)(6)2019 - Patient was diagnosed with recurrent incisional her

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

  MAUDE report 50837147 ↗
• InjuryJun 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, "THE PERIUMBILICAL HERNIA SAC WAS DISSECTED CIRCUMFERENTIALLY. A BARD FLAT MESH (DEVICE 1) WAS PLACED TO DEFECT AND SECURED TO FASCIA USING SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL EXPLANT OF BARD FLAT MESH AND IMPLANT OF PHASIX ST MESH (DEVICE 2). PER OP NOTES, "THERE WAS A FASCIAL DEFECT AT THE UMBILICUS AND LARGE HERNIA SAC IN EPIGASTRIC AREA WERE BRIDGED INTO ONE LARGE DEFECT. A PORTION OF PREVIOUSLY PLACED MESH (DEVICE 1) WAS EXCISED TO CREATE SMOOTH SURFACE. A SHEET OF PHASIX ST MESH (DEVICE 2) WAS PLACED IN ABDOMINAL WALL USING SUTURES." (B)(6) 2019 - PATIENT UNDERWENT REMOVAL OF ALL INFECTED MESH (DEVICE 1, 2). (NOTE: THERE IS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS) ATTORNEY ALLEGES THAT PATIENT HAD HERNIA RECURRENCE, INFECTION, NERVE DAMAGE, ABSCESS, ADHESION, FISTULA, SEROMA AND PAIN APPROX. FROM (B)(6) 2016 TO PRESENT.

  Patient problems: Abscess; Fistula; Nerve Damage; Pain; Unspecified Infection

  MAUDE report 25652081 ↗
• InjuryMar 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND DISSECTED FREE. THE HERNIA SAC WAS EXCISED. A VENTRALEX ST (DEVICE 1) WAS PLACED AND SUTURED CIRCUMFERENTIALLY.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS, SEROMA AND HEMATOMA THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE INCISION WAS OPENED. A CAVITY ABOVE THE PRIOR MESH WAS NOTED. IT CONTAINED SEROMA AND OLD HEMATOMA WERE EVACUATED.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA WITH INFECTED MESH, ABSCESS AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX ST (DEVICE 1) AND IMPLANT OF PHASIX ST (DEVICE 2). PER OP NOTES, ¿ABSCESS WAS ENCOUNTERED AND DRAINED. THE PRIOR MESH (DEVICE 1) WAS NOTED. THE OMENTUM ADHERENT TO MESH WAS EXCISED. THE INFECTED OMENTUM EXCISED. ALL THE ABSCESS CAVITY WAS DRAINED. THE INFECTED PRIOR MESH (DEVICE 1) WAS EXCISED COMPLETELY. THE HERNIA DEFECT WAS NOTED AND REDUCED. A PHASIX ST (DEVICE 2) WAS PLACED AND SUTURED.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WI

  Patient problems: Adhesion(s); Drug Resistant Bacterial Infection

  MAUDE report 24505050 ↗
• MalfunctionNov 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED ON (B)(6) 2025 DURING TWO SEPARATE CASES FOR HIATAL HERNIA REPAIR THE USER FACILITY REPORTS THAT THE FOIL POUCHES ONCE OPENED HAD PIN HOLES ALONG WITH DEEP SCRATCHES AND ARE CONCERNED THEY HAVE BEEN COMPROMISED. BREACH OF STERILITY. THEY ALLEGED THEY CAN SEE LIGHT THROUGH THE POUCH WHEN USING A FLASHLIGHT DURING INSPECTION. THE FACILITY PERFORMED AN INVENTORY INSPECTION OPENING MULTIPLE PRODUCTS (PHASIX ST, VENTRALIGHT ST, PHASIX OPS, PHASIX ECHO) WITH THE SAME CONDITION OF DAMAGE. THE TWO CASES WERE COMPLETED USING ANOTHER DEVICE THAT DID NOT EXHIBIT THE SAME ISSUE. THIS RESULTED IN AN INCONSEQUENTIAL DELAY. THERE WAS NO PATIENT HARM AS A RESULT OF THE PROBLEM EXPERIENCED. THIS MDR REPRESENTS THE 2 PHASIX ST MESH FROM LOT NUMBER HUKS0051 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649564 ↗
• MalfunctionNov 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED ON (B)(6) 2025 DURING TWO SEPARATE CASES FOR HIATAL HERNIA REPAIR THE USER FACILITY REPORTS THAT THE FOIL POUCHES ONCE OPENED HAD PIN HOLES ALONG WITH DEEP SCRATCHES AND ARE CONCERNED THEY HAVE BEEN COMPROMISED. BREACH OF STERILITY. THEY ALLEGED THEY CAN SEE LIGHT THROUGH THE POUCH WHEN USING A FLASHLIGHT DURING INSPECTION. THE FACILITY PERFORMED AN INVENTORY INSPECTION OPENING MULTIPLE PRODUCTS (PHASIX ST, VENTRALIGHT ST, PHASIX OPS, PHASIX ECHO) WITH THE SAME CONDITION OF DAMAGE. THE TWO CASES WERE COMPLETED USING ANOTHER DEVICE THAT DID NOT EXHIBIT THE SAME ISSUE. THIS RESULTED IN AN INCONSEQUENTIAL DELAY. THERE WAS NO PATIENT HARM AS A RESULT OF THE PROBLEM EXPERIENCED. THIS MDR REPRESENTS THE REPORTED 2 PHASIX ST MESH FROM LOT NUMBER HUHU1522 OPENED BY THE CUSTOMER. NOTE ONLY 1 MESH WAS RETURNED FOR THIS LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649282 ↗
• MalfunctionNov 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED ON (B)(6) 2025 DURING TWO SEPARATE CASES FOR HIATAL HERNIA REPAIR, THE USER FACILITY REPORTS THAT THE FOIL POUCHES ONCE OPENED HAD PIN HOLES ALONG WITH DEEP SCRATCHES AND ARE CONCERNED THEY HAVE BEEN COMPROMISED. BREACH OF STERILITY. THEY ALLEGED THEY CAN SEE LIGHT THROUGH THE POUCH WHEN USING A FLASHLIGHT DURING INSPECTION. THE FACILITY PERFORMED AN INVENTORY INSPECTION OPENING MULTIPLE PRODUCTS (PHASIX ST, VENTRALIGHT ST, PHASIX OPS, PHASIX ECHO) WITH THE SAME CONDITION OF DAMAGE. THE TWO CASES WERE COMPLETED USING ANOTHER DEVICE THAT DID NOT EXHIBIT THE SAME ISSUE. THIS RESULTED IN AN INCONSEQUENTIAL DELAY. THERE WAS NO PATIENT HARM AS A RESULT OF THE PROBLEM EXPERIENCED. THIS MDR REPRESENTS THE 1 PHASIX ST MESH FROM LOT NUMBER HUKS2055 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630793 ↗
• InjuryAug 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OP NOTES, "MIDLINE INCISION WAS MADE, A MEDIUM SIZED VENTRALEX ST MESH (DEVICE 1) WAS PLACED INTO THE FASCIAL EDGES." (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH HIATAL HERNIA AND CHRONIC GERD THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX ST MESH (DEVICE 2). (NOTE: NO OP NOTES WERE PROVIDED IN MR). (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH ESOPHAGEAL STENOSIS AFTER FUNDOPLICATION WITH DYSPHAGIA, EPIGASTRIC PAIN AND EXTENSIVE ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OP NOTES, "LYSIS OF ADHESIONS OF THE OMENTUM FROM THE ANTERIOR ABDOMINAL WALL TO THE OLD MESH. THERE WERE ADHESIONS ABOVE THE LEVEL OF THE HIATUS FAIRLY INTENSE THAT WERE TAKEN DOWN."

  Patient problems: Adhesion(s); Pain; Stenosis

  MAUDE report 22858497 ↗
• InjuryJul 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2006 ¿ PATIENT WAS DIAGNOSED WITH LARGE VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE # 1). PER OP NOTES, ¿THE HERNIA DEFECT IN THE UPPER ABDOMEN WAS REPAIRED USING A LARGE OVAL COMPOSIX KUGEL MESH (DEVICE # 1) AND ANCHORED USING SUTURES.¿ ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH RING BREAK THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF BROKEN MESH (DEVICE # 1). PER OP NOTES, ¿TWO ENDS OF THE BROKEN RING OF THE COMPOSIX KUGEL MESH (DEVICE # 1) WERE IDENTIFIED AND MESH MATERIAL APPEARED TO BUNCH UP IN THE PERIUMBILICAL AREA. THEN, TWO PORTIONS OF RING WERE REMOVED AND MOST OF RING WAS LEFT IN PLACE.¿ ON (B)(6) 2017 ¿ PATIENT UNDERWENT COLONOSCOPY WITH BIOPSY DUE TO ADHERENT SUTURE MATERIAL. ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA, RECURRENT VENTRAL HERNIA AND CONTAMINATED MESH EROSION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE # 1) AND IMPLANT OF PHASIX ST (DEVICE # 2). PER OP NOTES, ¿THE MESH (DEVICE #1) CONTRACTED AND FOLDED ONTO ITSELF HAD ERODED INTO BOWEL AT ILEOCOLIC ANASTOMOSIS. THERE WERE NUMEROUS LOOPS OF SMALL BOWEL STUCK TO THE UNDER

  Patient problems: Adhesion(s); Fistula; Fluid Discharge

  MAUDE report 22532640 ↗
• InjuryFeb 25, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY AND REVIEW OF PATIENT MEDICAL RECORDS: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS FREED UP FROM SURROUNDING TISSUES AND COMPLETELY REDUCED. THERE WAS A HERNIA DEFECT IN THE FASCIA. A VENTRALEX ST MESH (DEVICE #1) WAS PLACED IN THE ABDOMINAL CAVITY AND TACKED TO THE ANTERIOR ABDOMINAL WALL USING SUTURES.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE PREVIOUS HERNIA REPAIR WAS IDENTIFIED. THE VENTRALEX ST MESH (DEVICE #1) APPEARED TO BE CONTRACTED AND BECAME PULLED UP INTO THE HERNIA DEFECT RESULTING IN RECURRENCE. THE VENTRALEX ST MESH (DEVICE #1) WAS REMOVED, AND DEFECT WAS CLOSED WITH SUTURE.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿PATIENT WAS NOTED TO HAVE A FAIR AMOUNT OF SCARRING AROUND THE PREVIOUS HERNIA REPAIR. THE AREA OF CHRONIC DRAINAGE FR

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21455749 ↗
• MalfunctionJan 16, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THE CUSTOMER OPENED THE SHIPPING BOX AND NOTICED THE ALLEGED BLOOD STAIN OR FOREIGN SUBSTANCE ON THE PHASIX ST MESH PRODUCT BOX. THE IMAGE PROVIDED SHOWS PRODUCT CARTON WITH A RED COLORED STAIN/FOREIGN MATERIAL ON IT. THERE WAS NO PATIENT INVOLVEMENT, AND THE PRODUCT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516331 ↗
• InjuryAug 6, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING (B)(6) 2020 THE PATIENT UNDERWENT SURGERY FOR AN OSTOMY TAKE DOWN AND VENTRAL HERNIA REPAIR PROCEDURE USING TWO PIECES OF BARD/DAVOL PHASIX ST MESH, ONE FOR THE HERNIA (DEVICE #1), AND ONE FOR THE OSTOMY SITE (DEVICE #2). AS REPORTED, THE SURGICAL SITE WAS MODERATELY CONTAMINATED. AS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT EXPLANT OF MESH DUE TO SEVERE ADHESIONS TO BOWEL AND FISTULA.

  Patient problems: Adhesion(s); Fistula

  MAUDE report 12286793 ↗
• InjuryMay 23, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSITE MESH (COMPOSIX), COMPOSIX KUGEL HERNIA PATCH AND VENTRALEX ON (B)(6) 2014 AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2014 AND (B)(6) 2019. 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 11868988 ↗
• InjuryFeb 25, 2021Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES ADVERSE PATIENT OUTCOMES AGAINST BARD/DAVOL VENTRALEX ST MESH, VENTRALEX MESH AND PHASIX ST MESH: ON (B)(6) 2015: THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR AND AN INCISIONAL HERNIORRHAPHY FOR ABDOMINAL HERNIA. THE SURGEON HAD IMPLANTED A BARD/DAVOL VENTRALEX ST MESH TO REPAIR THE HERNIA. ON (B)(6) 2015: THE PATIENT PRESENTED TO THE SURGEON FOR A POST-OPERATIVE FOLLOW-UP. THE SURGEON OBSERVED DRAINAGE FROM THE PATIENT'S WOUND AND NOTED THAT THE PATIENT WAS COMPLAINING OF "ABDOMINAL PAIN WITH POSITION CHANGES". THE SURGEON SUGGESTED PHYSICAL LIMITATIONS AS THE PATIENT HEALED, AND TO RETURN WITH ANY PROBLEMS. ON (B)(6) 2015: DURING ANOTHER FOLLOW-UP, THE SURGEON NOTED THAT THE INCISION WAS PRODUCING LESS DRAINAGE, BUT THE PATIENT WAS STILL EXPERIENCING PAIN DURING POSITION CHANGES. ON (B)(6) 2020: THE PATIENT PRESENTED FOR AN ULTRASOUND TO CONFIRM THE CAUSE AND EXTENT OF FLUID ACCUMULATION CAUSING THE SURGEON TO EXPRESS CONCERN FOR AN ABSCESS RELATING TO THE VENTRALEX ST HERNIA SURGERY. ON (B)(6) 2015: THE PATIENT WAS COMPLAINING OF A "NEW ONSET EPIGASTRIC AND LEFT ABDOMINAL PAIN". THE PATIENT SUBSEQUENTLY UNDERWENT A CT SCAN OF ABDOMEN, IN WHICH THE SURGEON O

  Patient problems: Adhesion(s); Disability; Hernia

  MAUDE report 11382216 ↗
• InjuryDec 5, 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 PHASIX MESH ON (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 PHASIX MESH. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abdominal Pain; Hypersensitivity/Allergic reaction; Injury; Seroma

  MAUDE report 9415901 ↗
• InjuryJan 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF THE (B)(6), EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2017 - THE SUBJECT PATIENT UNDERWENT A ROBOTIC-ASSISTED UMBILICAL HERNIA REPAIR WITH IMPLANT OF THE PHASIX ST MESH. AT THIS TIME A CONCOMITANT PROCEDURE OF A BILATERAL TRANSVERSUS ABDOMINUS PLANE BLOCK WAS PERFORMED. THE PHASIX ST MESH WAS POSITIONED SO THAT ITS EDGES EXTEND BEYOND THE MARGINS OF THE DEFECT BY AT LEAST 5CM. THE MESH WAS FIXED IN PLACE WITH BOTH MECHANICAL (NON BARD/DAVOL SECURESTRAP) AND SUTURE. ON (B)(6) 2018 - THE SUBJECT PATIENT UNDERWENT A PHYSICAL EXAM IN WHICH THE CLINICIAN NOTED SUBCUTANEOUS ABDOMINAL WALL THICKENING. AS REPORTED, THERE WAS NO "IDENTIFIABLE FASCIAL DEFECT" ON EXAM AND THE PATIENT WAS SCHEDULED FOR AN ULTRASOUND TO CHECK FOR HERNIA RECURRENCE. ON (B)(6) 2019 - THE PATIENT UNDERWENT AN ULTRASOUND, WHICH SHOWED A HERNIA RECURRENCE. THE ABDOMINAL WALL THICKENING AND RECURRENCE HAVE BEEN ASSESSED PER THE CLINICIAN AS MILD AND AS BEING 'POSSIBLY RELATED' TO THE STUDY DEVICE AND 'POSSIBLY RELATED' TO THE INDEX PROCEDURE. THIS HERNIA RECURRENCE HAS BEEN ASSESSED AS MILD SEVERITY. THE INFORMATION PROVIDED INDICATES INTERVENTION IS REQUIRED TO

  Patient problems: Hernia

  MAUDE report 8265346 ↗
• InjuryJan 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF THE PHASIX ST STUDY (B)(6), EXPERIENCED A HERNIA RECURRENCE. (B)(6) 2016 - THE SUBJECT PATIENT UNDERWENT A ROBOTIC-ASSISTED UMBILICAL HERNIA REPAIR USING A BARD PHASIX ST MESH. AS REPORTED, THE PHASIX ST MESH WAS POSITIONED SO THAT ITS EDGES EXTEND BEYOND THE MARGINS OF THE DEFECT BY AT LEAST 5CM. MECHANICAL FIXATION WAS PERFORMED, USING A NON BARD/DAVOL FIXATION DEVICE. THE SUBJECT PATIENT ALSO UNDERWENT A BILATERAL INGUINAL HERNIA REPAIR USING BARD 3DMAX MESH AND A BILATERAL TRANSVERSUS ABDOMINUS PLANE BLOCK. (B)(6) 2018 - THE SUBJECT PATIENT WAS EVALUATED AT THE 24 MONTH VISIT. NO HERNIA WAS DETECTED UPON PHYSICAL EXAM. (B)(6) 2018 - THE SUBJECT PATIENT UNDERWENT AN ULTRASOUND IN WHICH A RECURRENT UMBILICAL HERNIA WAS DETECTED. THIS ADVERSE EVENT HAS BEEN ASSESSED BY THE CLINICIAN AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. AS REPORTED, ADDITIONAL INTERVENTION IS REQUIRED; HOWEVER, NO ACTION HAS BEEN TAKEN AT THIS TIME.

  Patient problems: Hernia

  MAUDE report 8252229 ↗
• InjurySep 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY ((B)(6)) EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2016 - THE SUBJECT PATIENT UNDERWENT HERNIA REPAIR USING THE PHASIX ST MESH. ON (B)(6) 2018 - THE SUBJECT PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE. THE HERNIA RECURRENCE WAS CONFIRMED VIA CT SCAN AND ULTRASOUND. ON (B)(6) 2018 - THE SUBJECT PATIENT UNDERWENT EXPLANT OF THE STUDY DEVICE. THE HERNIA RECURRENCE HAS BEEN ASSESSED PER THE CLINICIAN AS MODERATE IN SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE, AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Hernia

  MAUDE report 7854934 ↗