Phasix 1202025Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741095368), received between Aug 28, 2018 and Jun 18, 2026 — classified as 1 death, 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA IN THE LLQ AT PREVIOUS COLOSTOMY SITE AND MIDLINE INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X (DEVICE 1) AND COMPOSIX MESH (DEVICE 2). PER OP NOTES, "ALL THE OMENTUM ADHERENT TO THE ABDOMINAL WAS TAKEN DOWN. ADHESIOLYSIS WAS PERFORMED. THE INCISIONAL HERNIA IN THE PRIOR COLOSTOMY SITE WAS NOTED IN THE LLQ WAS REDUCED. A COMPOSIX E/X (DEVICE 1) WAS PLACED AND TACKED. MIDLINE INCISIONAL HERNIA WAS NOTED AND REDUCED. A COMPOSIX MESH (DEVICE 2) WAS PLACED AND TACKED." ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT MULTIPLE INCISIONAL HERNIA AND CHRONIC OPEN ABDOMINAL WALL WOUND AND MESH INFECTION AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX E/X (DEVICE 1), COMPOSIX MESH (DEVICE 2) AND IMPLANT OF PHASIX ST (DEVICE 3). PER OP NOTES, "TWO WOUND OPENINGS WERE EXCISED. TWO AREAS OF CHRONIC WOUND INFECTION PENETRATED DOWN TO THE MESH (DEVICE 1 AND 2). CULTURES WERE OBTAINED. DENSE ADHERENCE BETWEEN OMENTUM AND THE UNDERSIDE OF THE PRIOR MESHES (DEVICE 1 AND 2) WERE TAKEN DOWN. THE INFECTED OLD MESHES (DEVICE 1 AND 2) WITH TACKS

  Patient problems: Abdominal Pain; Abscess

  MAUDE report 25551992 ↗
• 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 HUKP1213 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630791 ↗
• 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 2 PHASIX ST MESH FROM LOT NUMBER HUKR1694 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630779 ↗
• 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 HUKS2023 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630778 ↗
• InjuryJul 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1) AND PHASIX ST MESH (DEVICE #2). PER OP NOTES, "THE FASCIAL LAYER WAS CLOSED WITH PHASIX ST MESH DEVICE #2) USING SUTURES AND THEN A VENTRALEX MESH (DEVICE #1) WAS PLACED AND TACKED." (B)(6) 2018 - PATIENT UNDERWENT INCISION AND DRAINAGE OF ABDOMINAL WALL ABSCESS AND WOUND DEBRIDEMENT. (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INFECTION, INCISIONAL VENTRAL HERNIA, GRANULOMAS THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF VENTRALEX MESH (DEVICE #1) AND PHASIX ST MESH (DEVICE #2) AND IMPLANT OF BIOLOGICAL MESH. PER OP NOTES, "INFECTED MESH (DEVICE #1 & #2) ALONG WITH ALL THE SUTURE MATERIAL AND TACKS WERE REMOVED. A BIOLOGICAL MESH WAS PLACED AND SUTURED."

  Patient problems: Abscess; Hernia; Unspecified Infection

  MAUDE report 22563632 ↗
• InjuryJul 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AS REPORTED, DURING A HERNIA REPAIR PROCEDURE ON (B)(6) 2023, PHASIX ST MESH WAS USED IN MIDLINE ABDOMEN AS A BRIDGING MESH WITHOUT ANY COMPLICATION. IT WAS REPORTED THAT 5 MONTHS POST IMPLANT, THE MESH WAS ERODING THROUGH THE ABDOMINAL WALL. ON (B)(6) 2024, SPLIT THICKNESS SKIN GRAFT WAS PLACED ON TOP OF GRANULATION TISSUE OVER THE PHASIX ST MESH. AS REPORTED, PATIENT IS STABLE, AND THE PHASIX ST MESH CONTINUES TO EXTRUDE OUT FROM THE SKIN GRAFT.

  Patient problems: Erosion

  MAUDE report 19642838 ↗
• InjuryApr 26, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN BARD/DAVOL PHASIX ST MESH (CATALOG # 1202025) ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PHASIX ST 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

  MAUDE report 19190578 ↗
• DeathMar 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT HAD A RECENT HISTORY OF MULTIPLE ENTEROCUTANEOUS FISTULAS FOLLOWING FORMATION OF STOMA AND HAD SUBSEQUENTLY BEEN TREATED AGGRESSIVELY FOR INFECTION. AS REPORTED, THE SURGEON BELIEVED THAT THE UNDERLYING INFECTION HAD CLEARED, AND FISTULAS HAD CLOSED AND WERE LOOKING TO REINFORCE THE PATIENT'S ABDOMINAL WALL AS IT WAS THE MAIN CONCERN AS SUCH A DECISION WAS MADE TO USE A PHASIX ST MESH BY ONLAY FASHION. ABOUT 2 WEEKS POST-IMPLANT, THE MESH WAS EXPLANTED DUE TO A MASSIVE SYSTEMIC INFECTION, DURING WHICH IT WAS NOTED THAT THE MESH WAS FLOATING IN PUS. AS REPORTED, THE SURGEON "DID NOT BELIEVE THAT THE MESH WAS AT FAULT IN THIS INSTANCE, BUT MORE LIKELY THAT THE INFECTION WASN¿T COMPLETELY RESOLVED. SURGEON STATED ON REFLECTION THAT MESH WAS NOT RESPONSIBLE FOR THIS IMMUNE RESPONSE. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY DUE TO COMPLICATIONS OF INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18955423 ↗
• InjuryMar 21, 2024Material Rupture; Material Rupture

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A PHASIX ST MESH ON (B)(6) 2021 FOR THE REPAIR OF A 2X4 CM HERNIA DEFECT. IN (B)(6) 2023, THE PATIENT EXPERIENCED A HERNIA RECURRENCE AND REVISITED THE SURGEON ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT UNDERWENT REPAIR, AND THE SURGEON STATES THE PREVIOUSLY PLACED MESH HAD ¿RUPTURED THROUGH THE CENTER.¿ THE PHASIX ST MESH WAS NOT REMOVED AS IT HAD ¿INTEGRATED INTO THE TISSUE WELL.¿ THE RECURRENCE WAS REPAIRED WITH THE IMPLANT OF A VENTRALIGHT ST MESH.

  Patient problems: Hernia

  MAUDE report 18951316 ↗
• InjuryFeb 22, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2001 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A LARGE HERNIA DEFECT WAS FOUND IN ABDOMINAL WALL FASCIA AND WAS DISSECTED OUT. A COMPOSIX E/X MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC INTO OPEN REPAIR WITH LYSIS OF ADHESIONS AND PARTIAL REMOVAL OF MESH. PER OPERATIVE NOTES, ¿A LARGE AMOUNT OF ADHESIONS WERE SEEN IN ABDOMEN AND WAS TAKEN DOWN. SMALL BOWEL WAS DENSELY ADHERENT TO THE MESH WHICH WAS BALLED AND IDENTIFIED A RECURRENT VENTRAL HERNIA. THE MESH WAS DENSELY INCORPORATED TO THE BOWEL AND IT WAS RESECTED. A LARGE AMOUNT OF PREVIOUS MESH WAS REMOVED AND A BIOLOGIC MESH WAS PLACED AROUND ABDOMINAL WALL TO COVER BOTH HERNIA DEFECTS.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND CHRONIC ABDOMINAL WOUND INFECTION THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE PURULENT MATERIAL WAS DRAINED AND REMOVED THE LOOSE PIECE OF PROLENE SUTURE WITH KNOTS. A COMPOSITE MESH WAS FOUND WHICH

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 18755691 ↗
• InjuryOct 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED ON (B)(6) 2023 THE PATIENT WAS IMPLANTED WITH PHASIX ST MESH. POST IMPLANT THE PATIENT PRESENTED WITH CELLULITIS AND WAS TREATED WITH ANTIBIOTICS. ABOUT SEVEN MONTHS POST IMPLANT THE PATIENT PRESENTED TO THE ED WITH A SEROMA AND WAS TREATED WITH ANTIBIOTICS. AS REPORTED THE SEROMA ¿CLEARED WELL¿ AND THE SURGEON WAS ¿HAPPY WITH HOW EVERYTHING LOOKED, AND SCANS LOOKED POSITIVE.¿ THE PATIENT ¿PRESENTED AGAIN WITH ANOTHER CASE OF SEROMA/CELLULITIS¿ AND THE SURGEON DECIDED TO REMOVE THE MESH. ON (B)(6) 2023 THE PATIENT UNDERWENT A REVISION PROCEDURE, AND THE MESH WAS EXPLANTED. AS NOTED, ¿THE LATERAL PART OF THE MESH HAD INTEGRATED/ABSORBED SO HE WASN'T CONCERNED, HOWEVER THROUGH THE MIDLINE THE MESH (APPROX. 70 %) HAD NOT INTEGRATED AT ALL, AND THIS WAS WHERE THE MESH WAS INFECTED. AS REPORTED, ¿THE MESH WAS ESSENTIALLY FLOATING BETWEEN THE MUSCLE LAYERS WITHOUT ANY INTEGRATION.

  Patient problems: Cellulitis; Seroma; Unspecified Infection

  MAUDE report 17881160 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL DVL-HE-020: ON (B)(6) 2017, SUBJECT PATIENT UNDERWENT AN OPEN MULTIPLE RECURRENT MIDLINE INCISIONAL HERNIA REPAIR PROCEDURE. A BARD/DAVOL PHASIX ST MESH, WAS PLACED IN SANDWICH FASHION INTRA-PERITONEALLY AND SUTURED. CLOSURE OF UPPER PORTION OF FASCIA WAS LIMITED DUE TO SOME OF THE HERNIA SAC. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017. ON (B)(6) 2017, SUBJECT PATIENT WAS DIAGNOSED WITH SEROMA AND UNDERWENT AN ULTRASOUND-GUIDED NEEDLE ASPIRATION OF THE SEROMA, WERE 190ML OF YELLOW SEROUS FLUID WAS ASPIRATED AND THE PATIENT TOLERATED WELL. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED. ON (B)(6) 2018, SUBJECT PATIENT WAS DIAGNOSED WITH A MESH INFECTION, SURGICAL SITE INFECTION (SSI) WITH PURULENT DRAINAGE; ABDOMINAL WALL ABSCESS AND ENTEROCUTANEOUS FISTULA. THE PATIENT WAS TREATED WITH INTRAVENOUS AND ORAL ANTIBIOTICS. THE PATIENT UNDERWENT SURGERY FOR EXTENSIVE LYSIS OF ADHESIONS, SMALL BOWEL RESECTION, ANAST

  Patient problems: Abscess; Adhesion(s); Fistula; Unspecified Infection

  MAUDE report 14489782 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2017 - SUBJECT PATIENT UNDERWENT AN OPEN MULTIPLE RECURRENT MIDLINE INCISIONAL HERNIA REPAIR PROCEDURE. A BARD/DAVOL PHASIX ST MESH, WAS PLACED IN SANDWICH FASHION INTRA-PERITONEALLY AND SUTURED. CLOSURE OF UPPER PORTION OF FASCIA WAS LIMITED DUE TO SOME OF THE HERNIA SAC. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017. (B)(6) 2017 - SUBJECT PATIENT WAS DIAGNOSED WITH SEROMA AND UNDERWENT AN ULTRASOUND-GUIDED NEEDLE ASPIRATION OF THE SEROMA, WERE 190ML OF YELLOW SEROUS FLUID WAS ASPIRATED AND THE PATIENT TOLERATED WELL. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED. (B)(6) 2018 - SUBJECT PATIENT WAS DIAGNOSED WITH A MESH INFECTION, SURGICAL SITE INFECTION (SSI) WITH PURULENT DRAINAGE; ABDOMINAL WALL ABSCESS AND ENTEROCUTANEOUS FISTULA. THE PATIENT WAS TREATED WITH INTRAVENOUS AND ORAL ANTIBIOTICS. THE PATIENT UNDERWENT SURGERY FOR EXTENSIVE LYSIS OF ADHESIONS, SMALL BOWEL RESECTION, ANA

  Patient problems: Seroma

  MAUDE report 14489650 ↗
• InjuryJun 18, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2017 - THE SUBJECT PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF AN EPIGASTRIC HERNIA WITH IMPLANT OF THE PHASIX ST MESH. THE PHASIX ST MESH WAS POSITIONED SO THAT ITS EDGES EXTEND BEYOND THE MARGINS OF THE DEFECT BY AT LEAST 5CM. NON BARD/DAVOL MECHANICAL FIXATION WAS USED TO SECURE THE MESH. THE FASCIA WAS COMPLETELY RE-APPROXIMATED AT THE CLOSE OF THE PROCEDURE WITH NON-ABSORBABLE SUTURES. THE HERNIA SITE WOUND IS CLASSIFIED AS "CLEAN." ON (B)(6) 2019 - THE SUBJECT PATIENT WAS EVALUATED AT HER 18 MONTH FOLLOW UP VISIT . AS REPORTED, THERE WAS EVIDENCE OF A HERNIA RECURRENCE WITHIN APPROXIMATELY 5CM OF THE INDEX HERNIA REPAIR. THE HERNIA RECURRENCE IS ASSESSED BY THE CLINICIAN AS MILD SEVERITY, "DEFINITELY RELATED" TO THE STUDY DEVICE AND "NOT RELATED" TO THE PROCEDURE. AS REPORTED PER CLINICAL COORDINATOR, THE PATIENT WILL UNDERGO A CT SCAN TO EVALUATE AND CONFIRM THE HERNIA RECURRENCE. AS REPORTED SURGICAL INTERVENTION IS REQUIRED; HOWEVER, NO ADDITIONAL SURGERY HAS BEEN SCHEDULED AT THIS TIME.

  Patient problems: Hernia

  MAUDE report 8709653 ↗
• InjuryMay 7, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT IN (B)(6) 2019 THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL PHASIX ST MESH DURING AN ABDOMINAL WALL REPAIR PROCEDURE. POSTOPERATIVELY THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR A POSSIBLE INFECTION. THE SURGEON REQUESTED A SURGEON TO SURGEON CONSULT REGARDING THE PATIENT'S TREATMENT. THE SURGEON REPORTS THAT SHE WAS SATISFIED WITH THE TREATMENT PLAN THAT WAS DISCUSSED DURING THE CONSULT. AS REPORTED THE SURGEON WILL CONTINUE TO TREAT THE PATIENT WITH ANTIBIOTICS THROUGHOUT THIS TIME. CURRENTLY THE WOUND IS CLOSED AND THE PATIENT IS RECOVERING FROM THE SURGERY IN HER HOME. ALSO REPORTED WAS FLUID BUILD UP, IT IS UNCLEAR IF THIS IS A SEROMA, OR EXTRA FLUID FROM THE RESORPTION OF THE ST BARRIER, WHICH IS NOT UNCOMMON IN THE POSTOPERATIVE TIME PERIOD.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 8587927 ↗
• InjuryAug 28, 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) 2017 - THE SUBJECT PATIENT UNDERWENT A ROBOTIC ASSISTED REPAIR OF AN EPIGASTRIC HERNIA WITH IMPLANT OF A PHASIX ST MESH. THERE WAS A SWISS CHEESE TYPE CONFIGURATION OF MULTIPLE DISCREET HERNIAS PRESENT. ON (B)(6) 2018 - THE SUBJECT PATIENT EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2018 - THE SUBJECT PATIENT UNDERWENT ADDITIONAL SURGERY TO REMOVE THE PHASIX ST MESH AND REPAIR THE HERNIA WITH ANOTHER IMPLANT. IT IS NOTED THAT THE PHASIX ST MESH "DID NOT INCORPORATE." THE RECURRENCE HAS BEEN ASSESSED PER THE CLINICIAN AS MODERATE IN SEVERITY, AS DEFINITELY RELATED TO THE DEVICE, AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Hernia

  MAUDE report 7822234 ↗