Phasix 1191530Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741107610), received between Sep 10, 2020 and Jun 4, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (15 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL DVL-HE-018: THE SUBJECT PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2025 AND PATIENT UNDERWENT AN OPEN PRIMARY EXPLORATORY LAPAROTOMY AND SMALL BOWEL RESECTION DURING WHICH A PHASIX MESH WAS PLACED AND SECURED IN PLACE WITH ABSORBATACK. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBABLE MONOFILAMENT 0 PDS SUTURES AND AT LEAST 3 CM AND NO GREATER THAN 4 CM OVERLAP IN ALL DIRECTIONS (SUPERIOR, INFERIOR, AND LATERALLY) BEYOND THE MARGINS OF THE FASCIAL INCISION. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, PATIENT WAS DIAGNOSED WITH SEROMA ON CTAP SCAN AND DRAIN PLACED ON (B)(6) 2025. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, AND IT IS RECOVERING/RESOLVING. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

  Patient problems: Seroma

  MAUDE report 22144544 ↗
• InjuryMar 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT UNDERWENT AN OPEN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION, MESENTERIC LYMPH NODE DISSECTION, FLUORESCEIN ANGIOGRAPHY, APPENDECTOMY AND OMENTAL PEDICLE FLAP ON (B)(6) 2025, DURING WHICH THE PHASIX MESH ONLAY WAS TRIMMED AND IMPLANTED USING 2-0 PDS ABSORBABLE MONOFILAMENT SUTURE. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBING MONOFILAMENT 0 PDS SUTURES; AT 1CM APART. ON (B)(6) 2025, THE SUBJECT PATIENT HAD FEVER AND SWEATING; PATIENT TESTED NEGATIVE FOR COVID AND FLU. ON (B)(6) 2025, THE PATIENT VISITED THE HOSPITAL AND UNDERWENT ABDOMINAL EXAMINATION WHICH DIAGNOSED A POTENTIAL INTRA-ABDOMINAL FLUID COLLECTION OR ABSCESS. SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT CT SCAN. THE SCAN RESULTS FINDS THAT THE PATIENT HAD A VERY LARGE GAS AND FLUID CONTAINING COLLECTION IN ANTERIOR ABDOMINAL WALL, CONCERNING FOR ABSCESS. ANTIBIOTICS (ZOSYN AND VANC) WERE STARTED AND CONSULT TO IR PLACED FOR DRAINAGE OF FLUID. ON (B)(6) 2025, PATHOLOGY FOR CULTURE TAKEN WAS GRAM POSITIVE COCCI IN CLUSTERS (BACTERIAL INFECTION). AS REPORTED, THE ADVERSE EVENT HAS BEEN ASSESSED PER CLINICIAN (STUDY SITE INVESTI

  Patient problems: Abscess; Bacterial Infection

  MAUDE report 21687345 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AS REPORTED PER CLINICAL TRIAL DVL-HE-018: THE SUBJECT PATIENT UNDERWENT AN OPEN PRIMARY LAPAROTOMY WHIPPLE PROCEDURE WITH IMPLANT OF A TRIMMED PHASIX MESH ON (B)(6) -2024. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ABSORBING MONOFILAMENT 3-0 PDS SUTURES; AT 3CM APART, 23 FIXATION SUTURE POINTS WERE ACHIEVED. ON (B)(6) 2024, THE SUBJECT PATIENT EXPERIENCED ACUTE HYPOXIC RESPIRATORY FAILURE, WAS WORKING HARDER TO BREATHE, OXYGEN REQUIREMENTS BECAME HIGHER, HEART RATE INCREASED, MORE TACHYPNEIC. IV LASIX AND ABG COMPLETED. IT WAS REPORTED THAT SUBJECT PATIENT WAS INTUBATED, ARTERIAL LINE PLACED FOR ABG DRAWS, CT PE PROTOCOL AND SCAN OF ABDOMEN AND PELVIS WERE COMPLETED ALONG WITH CHEST X-RAYS. THE DEVICE WAS NOT ALTERED IN THE TREATMENT FOR THIS AE, OTHER MEDICAL INTERVENTIONS WERE UTILIZED. WEANING OFF THE VENTILATOR WAS PLANNED AS ABLE AND TO EXTUBATE WHEN APPROPRIATE. ON 20-NOV-2024, IT WAS REPORTED THAT ADVERSE EVENT WAS RESOLVED. AS REPORTED, THE ADVERSE EVENT (ACUTE HYPOXIC RESPIRATORY FAILURE) HAS BEEN ASSESSED PER CLINICIAN (STUDY SITE INVESTIGATOR) AS POSSIBLY RELATED TO THE STUDY DEVICE WITH A POSSIBLE RELATIONSHIP TO THE PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED BY

  Patient problems: Respiratory Failure

  MAUDE report 20914113 ↗
• InjuryFeb 1, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2024, THE SUBJECT PATIENT UNDERWENT AN EXPLORATORY PRIMARY LAPAROTOMY, LOW ANTERIOR AND SMALL BOWEL RESECTION, PARTIAL HEPATECTOMY, OMENTAL PEDICLE FLAB SECURED IN PELVIS WITH CONCOMITANT PARTIAL COLECTOMY, APPENDECTOMY, HYSTERECTOMY AND OOPHORECTOMY, DURING WHICH A BARD/DAVOL PHASIX MESH WAS TRIMMED, PLACED IN ONLAY FASHION AND SECURED WITH ABSORBABLE MONOFILAMENT 3.0 PDS SUTURES. A 3CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBABLE MONOFILAMENT 0 PDS SUTURES. SKIN CLOSURE WAS ACHIEVED USING STAPLES. ON (B)(6) 2024, THE SUBJECT PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION AND REQUIRED MEDICATION. PATIENT HAD 1 STAPLE REMOVED AND MIDLINE PROBED IN INFERIOR AREA WITH SMALL AMOUNT OF PUS- PACKED WITH GAUZE. A CT SCAN OF ABDOMEN AND PELVIS ON SHOWED NO ABDOMINAL OR PELVIS ABSCESS. KEFLEX WAS SWITCHED TO CEFAZOLIN IV. ON (B)(6) 2024, THE SUBJECT PATIENT WAS SEEN IN CLINIC AND THE LOWER PART OF THE INCISION STILL APPEARED ERYTHEMATOUS. AUGMENTIN WAS PRESCRIBED TO TREAT POSSIBLE SUPERFICIAL INFECTION. PATIENT IS SCHEDULED TO BE SEEN AGAIN ON (B)(6) 2024. THE REPORTED ADVERSE EVEN

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 18621747 ↗
• InjuryJan 31, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL DVL-HE-018: THE SUBJECT PATIENT UNDERWENT OPEN COLOSTOMY WITH END-TO-END ANASTOMOSIS AND ONLAY MESH REINFORCEMENT PROCEDURE WITH IMPLANT OF PHASIX MESH ON (B)(6) 2023. PATIENT PRESENTED TO ED WITH POST-OPERATIVE ABDOMINAL PAIN AND MIDLINE DISTENSION ON (B)(6) 2023 THEREBY UNDERWENT CT IMAGING WHICH SHOWED FLUID COLLECTION IN ANTERIOR ABDOMINAL WALL. IT WAS ALSO OBSERVED THAT COMPLETE BLOOD COUNT WAS NORMAL, AND THE FLUID GRAM STAIN LAB RESULT SUGGESTED NO CONCERN FOR INFECTION. ON (B)(6) 2023, THE PATIENT HAS BEEN DIAGNOSED WITH LARGE ABDOMINAL WALL SEROMA AND ELECTED TO ASPIRATE THE SEROMA AS THE PATIENT WAS EXPERIENCING DISCOMFORT. APPROXIMATELY 410ML OF SEROSANGUINOUS FLUID WAS REMOVED. RESULTS OF THE GRAM STAIN AND CULTURE SHOWED NO PMNS, NO ORGANISMS GROWTH AFTER FOUR DAYS. PATIENT IS UNDER FOLLOW UP. THE REPORTED ADVERSE EVENT (WOUND SEROMA) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS MILD IN SEVERITY. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND UADE (UNANTICIPATED ADVERSE DEVICE EVENT). ADDE

  Patient problems: Abdominal Pain; Seroma

  MAUDE report 18613400 ↗
• InjuryJun 8, 2023Migration; Migration

  AS REPORTED PER CLINICAL TRIAL DVL-HE-018: ON (B)(6) 2023, THE SUBJECT PATIENT UNDERWENT PRIMARY LAPAROTOMY-COLECTOMY PROCEDURE DURING WHICH A PHASIX MESH (DEVICE 1) WAS TRIMMED AND PLACED IN ONLAY FASHION USING SORBAFIX FIXATION DEVICE (DEVICE 2). THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2023. ON (B)(6) 2023, PATIENT HAD PAIN AND UNDERWENT CT SCAN WHICH REVEALED 3.5X3.5 CM HERNIA. ON (B)(6) 2023, THE PATIENT UNDERWENT A ROBOTIC ASSISTED RECURRENT HERNIA REPAIR PROCEDURE. IT WAS FOUND THE PREVIOUSLY PLACED PHASIX MESH MIGRATED ALLEGING THE SORBAFIX FASTENERS HAD FAILED TO HOLD THE IMPLANT IN PLACE. THE PHASIX (APPROX. 90%) WAS REMOVED/EXPLANTED. A PERMANENT SYNTHETIC MESH WAS USED TO TREAT THE HERNIA. THE ADVERSE EVENTS AS REPORTED REGARDING THE MESH DEVICE HAVE BEEN ASSESSED PER THE CLINICIAN AS SEVERE IN SEVERITY. THE REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EFFECT).

  Patient problems: Hernia

  MAUDE report 17085266 ↗
• InjuryMar 15, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(6). ON (B)(6) 2023 THE SUBJECT PATIENT UNDERWENT PRIMARY LAPAROTOMY-COLECTOMY PROCEDURE DURING WHICH A PHASIX MESH WAS TRIMMED AND PLACED IN ONLAY FASHION USING SORBAFIX FIXATION DEVICE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT WAS DIAGNOSED WITH A SEROMA. THE ADVERSE EVENT OF SEROMA HAS BEEN ASSESSED PER CLINICIAN AS MODERATE IN SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE, DEFINITELY RELATED TO THE PROCEDURE, AND RECOVERING/RESOLVING. NO ACTION HAS BEEN TAKEN. THE REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE UADE (UNANTICIPATED ADVERSE DEVICE EFFECT).

  Patient problems: Seroma

  MAUDE report 16544758 ↗
• InjuryJan 31, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  AS REPORTED PER PREVENT CLINICAL TRIAL (B)(4): ON (B)(6) 2021, THE SUBJECT PATIENT UNDERWENT PRIMARY LAPAROTOMY-OPEN COLOSTOMY REVERSAL PROCEDURE PERFORMED IN OPEN FASHION, DURING WHICH A PHASIX MESH WAS TRIMMED AND PLACED IN ONLAY TECHNIQUE. A 3CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. THE PHASIX MESH WAS SECURED IN PLACE WITH SUTURE FIXATION ONLY. THE FASCIA WAS CLOSED WITH ETHICON 1 PDS SUTURE, AND THE SKIN WAS FULLY CLOSED WITH STAPLES. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH A HERNIA AT STOMA SITE REDUCIBLE AND MINIMALLY SYMPTOMATIC. THE REPORTED ADVERSE EVENT (AE) HAS BEEN ASSESSED PER THE CLINICIAN AS DEFINITELY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY WITH NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED AT THIS TIME. AS REPORTED, THE AE DOES NOT MEET THE CRITERIA OF A SAE (SERIOUS ADVERSE EVENT), OR A UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

  Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272161 ↗
• InjuryNov 17, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(4): ON (B)(6) 2021 THE SUBJECT PATIENT UNDERWENT AN OPEN PRIMARY LAPAROTOMY DUODENAL SLEEVE RESECTION PROCEDURE. A BARD/DAVOL PHASIX MESH WAS TRIMMED AND IMPLANTED IN ONLAY FASHION AND WAS FIXATED USING A BARD/DAVOL SORBAFIX FIXATION DEVICE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA. IT WAS REPORTED THAT PATIENT TO RETURN IN JULY FOR CT-SCAN TO DETERMINE IF PATIENT HAS HAD RECURRENCE OF DISEASE. IF NO RECURRENCE, PATIENT WILL UNDERGO TREATMENT FOR THE HERNIA. THIS AE HAS BEEN ASSESSED PER STUDY CLINICIAN AS NOT RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED PER THIRD PARTY CLINICIAN AS DEFINITELY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED AS NOT RECOVERED/RESOLVED, MODERATE SEVERITY AND A SERIOUS ADVERSE EVENT (SAE) BUT DOES NOT MEET THE DEFINITION OF AN UNANTICIPATED ADVERSE DEVICE EFFECT (UADE).

  Patient problems: Hernia

  MAUDE report 15821726 ↗
• InjuryMay 11, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER PREVENT CLINICAL TRIAL (B)(4): AS REPORTED, DURING AN OPEN RELAPAROTOMY OSTOMY TAKEDOWN PROCEDURE ON (B)(6) 2021, THE STUDY PATIENT WAS IMPLANTED WITH A BARD/DAVOL PHASIX MESH WHICH WAS TRIMMED AND PLACED IN AN ONLAY FASHION. AS REPORTED, THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION ON (B)(6) 2022 UNRELATED TO THE DEVICE AND UNDERWENT EXPLORATORY LAPAROTOMY ON THE SAME DAY. PER THE OP NOTE, "AS WE EXTENDED OUR SKIN INCISION DOWN THROUGH HER LOWER ABDOMINAL WOUND, WE ENCOUNTERED SOME PURULENT MATERIAL AND ENCOUNTERED THE PATIENT'S PREVIOUSLY PLACED PROPHYLACTIC MESH. THE MESH WAS REMOVED IN MULTIPLE PIECES USING SHARP DISSECTION. THE WOUND DID APPEAR GROSSLY CONTAMINATED." AS REPORTED, THE PHASIX MESH WAS COMPLETELY REMOVED A WOUND VAC WAS PLACED AT THE INCISION SITE. AS REPORTED, THE PATIENT WAS DIAGNOSED WITH SUPERFICIAL SURGICAL SITE INFECTION; DRAINAGE CULTURE WAS POSITIVE FOR ESCHERICHIA COLI, THE PATIENT WAS TREATED WITH IV AND ORAL ANTIBIOTICS AND WAS DISCHARGED ON (B)(6) 2022. AS REPORTED, THIS ADVERSE EVENT IS RESOLVING; HAS BEEN ASSESSED PER THE STUDY CLINICIAN AS MODERATE IN SEVERITY, POSSIBLY RELATED THE STUDY DEVICE. THE AE MEETS THE DEFINITION OF A S

  Patient problems: Bacterial Infection

  MAUDE report 14364975 ↗
• InjuryApr 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER PREVENT CLINICAL TRIAL (B)(4): ON (B)(6) 2021 THE SUBJECT PATIENT UNDERWENT AN OPEN LAPAROTOMY WHIPPLE PROCEDURE (PANCREATICODUODENECTOMY). A PHASIX MESH WAS TRIMMED WITH A 3CM OVERLAP AND PLACED IN ONLAY FASHION AND WAS FIXATED USING A BARD/DAVOL SORBAFIX FIXATION DEVICE WITH 20 FIXATION POINTS PLACED 2CM APART WITH A NON-BARD/DAVOL 1-PDS SLOW ABSORBING MONOFILAMENT MECHANICAL SUTURE IN A RUNNING STITCH TECHNIQUE. FULL SKIN CLOSURE WAS ACHIEVED WITH LONG-TERM ABSORBABLE SUTURE AND STAPLES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021. AS REPORTED, ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH WOUND DEHISCENCE. IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT DEVELOPED 2 OPEN AREAS IN THE MIDPOLE OF THEIR INCISION WHICH IS TRACKING ANTERIORLY AND WAS SCHEDULED FOR WASHOUT AND ABDOMINAL WOUND CLOSURE WITH NO SIGNS OF INFECTION. AS REPORTED, THE PATIENT WAS DIAGNOSED WITH DELAYED WOUND HEALING AND A WOUND VAC WAS PLACED ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT APPEARS TO BE EXPERIENCING A CASCADING COMPLICATION ASSOCIATED WITH WOUND HEALING ISSUES REQUIRING ONGOING MEDICAL TREATMENT. THIS AE IS CLINICALLY ASSESSED TO BE POSSIBLY RELATED TO THE STUDY DEVIC

  Patient problems: Diarrhea; Hypoxia; Impaired Healing; Sepsis; Wound Dehiscence

  MAUDE report 14234120 ↗
• InjuryDec 14, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER PREVENT CLINICAL TRIAL (B)(6): ON (B)(6) 2021, DURING AN OPEN RELAPAROTOMY OSTOMY PROCEDURE, THE STUDY PATIENT WAS IMPLANTED WITH A BARD/DAVOL PHASIX MESH WHICH WAS TRIMMED AND PLACED IN AN ONLAY FASHION. SKIN INCISIONS ( SIZE-18CM) WERE MADE STRAIGHT NEAR THE EPIGASTRIC AND UMBILICAL REGION. MIDLINE FASCIA CLOSURE WAS ACHIEVED USING A NON-BARD/DAVOL SINGLE SUTURE, IN A RUNNING STITCH TECHNIQUE. ALSO, AN ABSORBABLE 1-PDS SUTURE WAS USED FOR SECURING THE MESH AND FINAL SKIN CLOSURE WAS ACHIEVED WITH STAPLES. AS REPORTED, THERE WAS NO ACTIVE SKIN PATHOLOGY AT THE TIME OF IMPLANT AND ANTIBIOTICS WERE ADMINISTERED PERI-OPERATIVELY; THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. AS REPORTED, ON (B)(6) 2021, THE STUDY PATIENT WAS DIAGNOSED WITH A HEMATOMA THAT REQUIRED STAPLE REMOVAL. THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS ADMINISTERED VANCOMYCIN (750MG) EVERY 12 HRS. ON ADMISSION AND SWITCHED TO PO AUGMENTIN ON ADMIT DAY. AS REPORTED, THE HEMATOMA WAS EVACUATED BEDSIDE IN THE EMERGENCY DEPARTMENT. CULTURE WAS NOT TAKEN. THE STAPLES WERE REMOVED AT THE LOWER INCISION AND THE STUDY PATIENT WAS DISCHARGED HOME WITH THREE TIMES WEEKLY DRESSING

  Patient problems: Hematoma; Obstruction/Occlusion

  MAUDE report 13006110 ↗
• InjuryDec 14, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER PREVENT CLINICAL TRIAL (B)(4): ON (B)(6) 2021, THE SUBJECT PATIENT UNDERWENT AN OPEN LAPAROTOMY WHIPPLE PROCEDURE WITH IMPLANT OF A BARD/DAVOL PHASIX MESH, PLACED IN ONLAY FASHION. THE PHASIX MESH WAS TRIMMED WITH A 3CM OVERLAP, AND WAS FIXATED USING A SORBAFIX FIXATION DEVICE WITH 20 FIXATION POINTS PLACED 2CM APART. MIDLINE FASCIA CLOSURE WAS ACHIEVED WITH A NON-BARD/DAVOL 2-PDS SLOW ABSORBING MONOFILAMENT SUTURE IN A RUNNING STITCH TECHNIQUE. FULL SKIN CLOSURE WAS ACHIEVED WITH LONG-TERM ABSORBABLE SUTURE AND STAPLES. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. AS REPORTED, THE SUBJECT PATIENT HAD SYMPTOMS OF ABDOMINAL PAIN, VOMITING AND WAS DIAGNOSED WITH A WOUND INFECTION ON (B)(6) 2021. AS REPORTED, THE ABDOMINAL PAIN AND VOMITING (MILD SEVERITY) WERE REPORTED AS POSSIBLY RELATED TO THE STUDY DEVICE AND HAVE RESOLVED WITHOUT INTERVENTION ((B)(6) 2021); THE PATIENT WAS TREATED WITH PRESCRIPTION MEDICATION TO TREAT THE WOUND INFECTION (MODERATE SEVERITY), REPORTED TO BE DEFINITELY RELATED TO THE STUDY DEVICE AND INDEX PROCEDURE AND HAS NOT RESOLVED.

  Patient problems: Abdominal Pain; Post Operative Wound Infection; Vomiting

  MAUDE report 13004609 ↗
• InjuryDec 7, 2021Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  AS REPORTED PER PREVENT CLINICAL TRIAL (B)(4): ON (B)(6) 2021, THE SUBJECT PATIENT UNDERWENT AN OPEN PRIMARY LAPAROTOMY TO PERFORM A WHIPPLE PROCEDURE WITH THE IMPLANT OF THE BARD/DAVOL PHASIX MESH, PLACED IN ONLAY FASHION. THE PHASIX MESH WAS TRIMMED AND ADEQUATE OVERLAP OF THE DEFECT WAS ACHIEVED. MECHANICAL FIXATION WAS USED (BARD/DAVOL SORBAFIX) TO FIXATE THE MESH WITH 16 FIXATION POINTS SPACED 3CM APART. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH NON-BARD/DAVOL, 1PDS SLOW ABSORBING MONOFILAMENT SUTURE IN A RUNNING STITCH TECHNIQUE. A SKIN CLOSURE WAS ACHIEVED WITH LONG-TERM ABSORBABLE SUTURE IN A RUNNING STITCH. IT WAS REPORTED THAT ON (B)(6) 2021, THE SUBJECT PATIENT WAS DISCHARGED. AS REPORTED, THE SUBJECT PATIENT WAS DIAGNOSED WITH A POSTOPERATIVE SEROMA DURING AN OFFICE VISIT ON (B)(6) 2021. BASED ON THE PATIENT DESCRIPTION, WOUND LEAKAGE "MOST-CONSISTENT" WITH A SEROMA AND FAT NECROSIS THAT HAS DECOMPRESSED SPONTANEOUSLY (WITHOUT TREATMENT). AT THIS TIME THE CLINICIAN INDICATES THERE IS NO CONCERN FOR INFECTION AND THE AREA IS EXPECTED TO CLOSE IN THE NEXT 3-5 DAYS. THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED BY THE CLINICIAN TO BE DEFINITELY RELATED TO THE STUDY DEVI

  Patient problems: Necrosis; Seroma; Wound Dehiscence

  MAUDE report 12953916 ↗
• InjuryOct 19, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED BOWEL OBSTRUCTION POST IMPLANT OF THE PHASIX MESH. (B)(6) 2021 - THE SUBJECT PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY TO PERFORM A WHIPPLE PROCEDURE (PANCREATICDUODENECTOMY) DUE TO A MEDICAL HISTORY SIGNIFICANT FOR CANCER (MALIGNANT NEOPLASM OF HEAD OF PANCREAS). DURING THIS PROCEDURE A BARD/DAVOL PHASIX MESH WAS PLACED IN AN ONLAY FASHION AND MECHANICAL FIXATION (NON-BARD/DAVOL) WAS ACHIEVED TO SECURE THE MESH. A CHOLECYSTECTOMY WAS ALSO PERFORMED AT THIS TIME. (B)(6) 2021 - THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO HOME WITH NURSING CARE. (B)(6) 2021 - THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH BOWEL OBSTRUCTION. AS REPORTED, THE REPORTED AE OF BOWEL OBSTRUCTION HAS BEEN ASSESSED PER THE CLINICIAN AS DEFINITELY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE INDEX PROCEDURE AND MODERATE IN SEVERITY. ADDENDUM: THE REPORTED AE OF BOWEL OBSTRUCTION HAS BEEN ASSESSED PER THE CLINICIAN AS NOT RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY AND ALSO ASSESSED TO MEET THE DEFINITION OF A SAE (SE

  Patient problems: Obstruction/Occlusion

  MAUDE report 12656049 ↗
• InjuryJun 14, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED SEROMA POST-IMPLANT OF PHASIX MESH. ON (B)(6) 2021 - THE SUBJECT PATIENT UNDERWENT AN OPEN COLOSTOMY REVERSAL PROCEDURE. A BARD/DAVOL PHASIX MESH TRIMMED AND PLACED IN ONLAY TECHNIQUE. A 3CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. THE PHASIX MESH WAS SECURED IN PLACE WITH SUTURE FIXATION ONLY AND THE MIDLINE FASCIA WAS CLOSED BY RUNNING STITCH USING NON BARD/DAVOL 1 PDS SUTURE. THE SKIN WAS FULLY CLOSED WITH STAPLES. ON (B)(6) 2021 - THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL. (B)(6) ON 2021 - THE SUBJECT PATIENT WAS DIAGNOSED WITH A SEROMA. THE REPORTED ADVERSE EVENT (AE) HAS BEEN ASSESSED PER THE CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE AE HAS BEEN ASSESSED AS MILD IN SEVERITY AND IS RECOVERING/RESOLVING AT THIS TIME WITH NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: Seroma

  MAUDE report 11990556 ↗
• InjuryApr 21, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A WOUND OPENING WITH PHASIX MESH EXPOSURE. (B)(6) 2021- THE SUBJECT PATIENT UNDERWENT A WHIPPLE PROCEDURE (PANCREATICODUODENECTOMY), PERFORMED IN OPEN FASHION. INCISIONS WERE MADE IN THE MID-UPPER ABDOMEN. A BARD/DAVOL PHASIX MESH, WAS TRIMMED AND PLACED AS AN ONLAY. OVERLAP WAS ACHIEVED AND THE SKIN WAS CLOSED WITH A NON BARD/DAVOL, ETHICON SUTURE. (B)(6) 2021 - THE SUBJECT PATIENT EXPERIENCED A WOUND OPENING WITH PHASIX MESH EXPOSURE. ADDITIONALLY, THE PATIENT HAS ABDOMINAL PAIN WITH CONSTANT WHITE PUS DRAINAGE. AS REPORTED, THE THE OUTCOME OF THE ADVERSE EVENT IS RECOVERING/RESOLVING. THE SEVERITY IS REPORTED TO BE MILD WITH NO ACTION TAKEN. THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. ADDENDUM: (B)(6) 2021 - THE INITIAL AE PROGRESSED AND THE SUBJECT PATIENT WAS HOSPITALIZED FOR A 1X1X2CM MIDLINE SKIN DEHISCENCE AND A WOUND VAC WAS PLACED. (B)(6) 2021 - THE PATIENT WAS DISCHARGED. AS REPORTED, THE AE HAS BEEN ASSESSED AS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE EVENT H

  Patient problems: Abdominal Pain; Purulent Discharge; Wound Dehiscence

  MAUDE report 11703532 ↗
• InjuryJan 29, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A WOUND DEHISCENCE AND SEROMA. ON (B)(6) 2020 - THE PATIENT UNDERWENT ONLAY PLACEMENT OF A PHASIX MESH, THE MESH WAS TRIMMED TO 25 CM LENGTH AND 8 CM WIDTH AND WAS FIXATED USING SUTURES WITH A 3 CM OVERLAP IN ALL DIRECTIONS. ON (B)(6) 2020 - THE PATIENT EXPERIENCED WOUND DEHISCENCE WITHOUT MESH BEING EXPOSED. THE ADVERSE EVENT (AE) WAS ASSESSED BY THE CLINICIAN AS MILD IN SEVERITY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PER THE CLINICIAN, THE AE WAS POSSIBLY RELATED TO BOTH THE STUDY DEVICE AND THE INDEX PROCEDURE. ON (B)(6) 2020 ¿ THE PATIENT PRESENTED WITH A 2 CM SEROMA. THE ADVERSE EVENT (AE) WAS ASSESSED BY THE CLINICIAN AS MILD IN SEVERITY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PER THE CLINICIAN, THE AE WAS DEFINITELY RELATED TO BOTH THE STUDY DEVICE AND INDEX PROCEDURE. THE WOUND DEHISCENCE AND SEROMA ARE ASSESSED TO BE RECOVERING/RESOLVING.

  Patient problems: Seroma; Wound Dehiscence

  MAUDE report 11250443 ↗
• InjurySep 10, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A SEROMA. (B)(6) 2020: THE SUBJECT PATIENT UNDERWENT AN OPEN MIDLINE LAPAROTOMY FOR AORTO CELIAC MESENTERIC ARTERY BYPASS, WITH PLACEMENT OF A 6¿X12¿ RECTANGLE (15X30 CM) PHASIX MESH (CAT #1191530, LOT #HUDU0528). A 30 CM INCISION FROM THE XYPHOID TO THE PUBIS WAS MADE, THE PHASIX MESH WAS TRIMMED TO 13 X 30 CM AND PLACED IN ONLAY FASHION. A MINIMUM OF 3CM OVERLAP WAS ACHIEVED IN ALL DIRECTIONS OF THE INCISION SITE (CLASS I, CLEAN WOUND). PERIMETER FIXATION OF THE MESH WAS ACHIEVED BY USING 30 SORBAFIX FASTENERS, PLACED 2CM APART. NON-BARD/DAVOL SUTURES PLACED 2CM APART (1-PDS) WERE USED FOR FASCIA AND SKIN CLOSURE. THE PATIENT WAS ADMINISTERED CLINDAMYCIN PERIOPERATIVELY. (B)(6) -2020: THE PATIENT WAS DISCHARGED TO HOME. (B)(6) 2020: THE SUBJECT PATIENT WAS DIAGNOSED WITH A SEROMA. THE AE WAS ASSESSED AS NOT RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE SEROMA WAS ASSESSED TO BE OF MODERATE SEVERITY AND NOT RESOLVED. (B)(6) 2020: THE SUBJECT PATIENT'S SEROMA WAS REPORTED TO HAVE WORSENED; 420ML OF FLUID IN THE PERIUMBILICAL REGION WAS ASPIRATED BY THE PI WITH NO IND

  Patient problems: Seroma

  MAUDE report 10513280 ↗