Phasix 1201520Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00801741095351), received between Mar 14, 2018 and Mar 13, 2026 — classified as 30 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿HERNIA SAC WAS IDENTIFIED. THE BARD FLAT MESH (DEVICE 1) WAS PLACED ON TOP OF PRIMARY REPAIR AND SECURED WITH THE PREVIOUSLY PLACED CIRCUMFERENTIAL TRANSFASCIAL SUTURES.¿ ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, ¿THE PATIENT WAS NOTED TO HAVE A SUBXIPHOID RECURRENT HERNIA APPROXIMATELY BASEBALL IN SIZE ABOVE THE LEVEL OF THE PREVIOUSLY PLACED ONLAY MARLEX MESH. BOWEL WAS STUCK TO A SMALL HERNIA BETWEEN MESH AND FASCIA. THE MESH WAS STILL ADHERENT TO FASCIA WAS LEFT IN PLACE AND THE REDUNDANT MESH (DEVICE 1) EXCISED WHERE FASCIA HAD PULLED AWAY. ADHESION TO THE ANTERIOR ABDOMINAL WALL WERE ALL TAKEN DOWN. FREE FLOATING MESH (DEVICE 1) WAS ALSO EXCISED. AN PHASIX MESH (DEVICE 2) WAS PLACED UNDERLAY IN INTRAPERITONEAL WITH COATED SIDE FACING THE BOWEL USING SUTURES.¿ ON (B)(6)2018 ¿ PATIENT WAS DIAGNOSED WITH NONHEALING SURGICAL WOUND THEREBY UNDERWENT

  Patient problems: Fistula; Impaired Healing

  MAUDE report 24597085 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿A MODERATE SIZED HERNIA WAS NOTED. THE MESH DID SEEM TO BE PULLED TO THE RIGHT, AND THE HERNIA DEFECT WAS TO THE LEFT. THE HERNIA SAC WAS EXCISED. A LARGE VENTRALEX MESH (DEVICE 1) WAS PLACED INTO DEFECT AND SUTURED.¿ (NOTE: THE MESH SEEN DURING THIS PROCEDURE WAS UNKNOWN) ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, ¿THE BOWEL WAS DISSECTED FROM THE INTERNAL PORTION OF SAC, MESH AND ABDOMINAL WALL. SEVERAL MESH (DEVICE 1) PARTICLES WERE REMOVED. THE BOWEL WAS TAKEN DOWN FROM ADHESION. A VENTRALEX MESH (DEVICE 2) WAS PLACED AND SEWN INTO STRONG FASCIA.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 2) AND IMPLANT OF XENMATRIX AB (DEVICE 3). PER OP NOTES, ¿THE PATIENT HAD NUMEROUS HERNIAS REPAIRED IN THE PELVIS SECONDARY TO C-SECTIONS. SMALL DILATED LOOPS OF

  Patient problems: Necrosis; Seroma; Wound Dehiscence

  MAUDE report 24575421 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2008:PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿A MODERATE SIZED HERNIA WAS NOTED. THE MESH DID SEEM TO BE PULLED TO THE RIGHT, AND THE HERNIA DEFECT WAS TO THE LEFT. THE HERNIA SAC WAS EXCISED. A LARGE VENTRALEX MESH (DEVICE 1) WAS PLACED INTO DEFECT AND SUTURED.¿ (B)(6) 2009: PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, ¿THE BOWEL WAS DISSECTED FROM THE INTERNAL PORTION OF SAC, MESH AND ABDOMINAL WALL. SEVERAL MESH (DEVICE 1) PARTICLES WERE REMOVED. THE BOWEL WAS TAKEN DOWN FROM ADHESION. A VENTRALEX MESH (DEVICE 2) WAS PLACED AND SEWN INTO STRONG FASCIA.¿ (B)(6) 2016: PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 2) AND IMPLANT OF XENMATRIX AB (DEVICE 3). PER OP NOTES, ¿THE PATIENT HAD HAD NUMEROUS HERNIAS REPAIRED IN THE PELVIS SECONDARY TO C-SECTIONS. SMALL DILATED LOOPS OF BOWEL WERE NOTED. A CHRONICALLY INCARCERATED UMBILICAL HERNIA WAS

  Patient problems: Adhesion(s); Fistula; Hernia

  MAUDE report 24569825 ↗
• 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 HUKR1692 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630119 ↗
• 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 HUJQ2131 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630105 ↗
• MalfunctionNov 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED ON 05-NOV-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 HUKN1544 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630098 ↗
• InjuryJul 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL (DEVICE #1). PER OP NOTES, "A COMPOSIX KUGEL (DEVICE #1) WAS PLACED AD SUTURED." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH BOWEL PERFORATION, BACTERIAL INFECTION, RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH EXPLANT OF COMPOSIX KUGEL (DEVICE #1) AND IMPLANT OF PHASIX ST MESH (DEVICE #2). PER OP NOTES, "THE INFECTED COMPOSIX KUGEL (DEVICE #1) WAS REMOVED, AND A PHASIX ST MESH (DEVICE #2) WAS PLACED AD SUTURED." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INFECTION, NON-HEALING ABDOMINAL WOUND THEREBY UNDERWENT PARTIAL REMOVAL OF PHASIX ST MESH (DEVICE #2). PER OP NOTES, "THE PHASIX ST MESH (DEVICE #2) WAS EXCISED PARTIALLY AND REMOVED." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH MIDLINE ABDOMINAL WOUND THEREBY UNDERWENT WOUND DEBRIDEMENT. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WOUND THEREBY UNDERWENT WOUND DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 22478344 ↗
• InjuryJun 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND EXCISED. A VENTRALEX ST (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL & UMBILICAL HERNIA WITH ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX ST (DEVICE #2). PER OPERATIVE NOTES, ¿DENSE ADHESIONS OF SMALL BOWEL TO ABDOMINAL WALL WERE TAKEN. THE SMALL BOWEL WAS STUCK IN THE MESH WERE RELEASED. THE HERNIA SACS WERE IDENTIFIED AND REDUCED. A PHASIX ST (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH GASTROINTESTINAL FISTULA & WOUND DEHISCENCE THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF MESH (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE PREVIOUS MESH (DEVICE 1# & #2) WAS IDENTIFIED WITH FREE FLOATING SUTURES WERE REMOVED COMPLETELY. THE AREA OF FISTULA IDENTIFIED AND REPAIRED WITH SUTURES. WOUND VAC WAS PLACED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AND FISTULA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BIOLOGICAL MESH AND FISTULA REPAI

  Patient problems: Fistula; Wound Dehiscence

  MAUDE report 22193783 ↗
• InjuryJun 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2018 ¿ THE PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC COMBINED OPEN REPAIR WITH IMPLANT OF TWO PHASIX ST MESH (DEVICE #1 AND DEVICE #2). PER OPERATIVE NOTES, ¿THE BOWEL WAS SEEN ADHERED TO THE OLD MESH. A PHASIX ST MESH (DEVICE #1) WAS PLACED AND SUTURED. OVER THE SUPERIOR DEFECT, LAPAROSCOPICALLY ANOTHER PHASIX ST MESH (DEVICE #2) WAS PLACED AND TACKED. ¿ (B)(6) 2018 - THE PATIENT WAS DIAGNOSED WITH SEROMA AND ALLERGIC REACTION; ABDOMINAL PAIN UNDERWENT OPEN REPAIR WITH EXPLANT OF MESH (DEVICE #1 AND DEVICE #2). PER OPERATIVE NOTES, ¿THE ODOUR FREE EXUDATE WAS ASPIRATED AND MESH (DEVICE #1 AND DEVICE #2) WAS REMOVED. THE ALLERGIC MESH REACTION AND SEROMA WAS REMOVED AND STAPLED.¿

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

  MAUDE report 22124655 ↗
• InjuryOct 17, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PHASIX ST (CAT# 1201520) ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PHASIX ST (CAT# 1201520). 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 20469566 ↗
• InjuryMay 16, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A ROBOTIC LOW ANTERIOR RESECTION OF THE RECTUM WITH IMPLANT OF PHASIX ST AT PELVIC INLET ON (B)(6) 2021. ABSORBABLE V-LOC SUTURE WAS USED TO SEW THE MESH WITH SEPRAFILM SIDE TOWARD THE ABDOMEN AND NON-SEPRAFILM SIDE TOWARD PELVIS. ON (B)(6) 2024, PATIENT UNDERWENT A HAND-ASSISTED LAP SMALL BOWEL RESECTION (X2) WITH ASSOCIATED TAKEDOWN OF ENTEROVAGINAL FISTULA, INCIDENTAL APPENDECTOMY, END COLOSTOMY REVISION AND RESIDUAL MESH WAS FOUND WITHIN THE FISTULA TRACK. SURGEON REPORTS THE MESH DID NOT ABSORB FAST ENOUGH, CREATED INFLAMMATION CAUSING ADHERENCE TO MESH AND VAGINAL CUFF. IT WAS REPORTED THAT PATIENT IS NOW STABLE AND WAS DISCHARGED.

  Patient problems: Adhesion(s); Fistula; Inflammation

  MAUDE report 19330024 ↗
• InjuryJan 18, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 20×15 DUAL LAYER PHASIX MESH ON (B)(6) 2023. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 20×15 DUAL LAYER PHASIX 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 18532581 ↗
• InjuryDec 12, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WITH PREVIOUS SURGICAL HISTORY OF COMPONENT SEPARATION AND INCISIONAL HERNIA REPAIR WAS IMPLANTED WITH PHASIX ST MESH DURING AN ILEOSTOMY PROCEDURE ON (B)(6) 2023. THE SURGEON LEFT POST OP DRAINS IN PLACE FOR 2 WEEKS. THE PATIENT DEVELOPED AN ABSCESS SHORTLY AFTER DRAIN REMOVAL AND IS NOW BEING TREATED WITH IV ANTIBIOTICS FOR 2 WEEKS. THE PATIENT HAD SUPPRESSIVE ANTIBIOTICS FOR SEVERAL MONTHS AS THE ABSCESS CULTURE RETURNED POSITIVE WITH MRSA BACTERIA. IT WAS REPORTED THAT THE SURGEON LEFT THE PHASIX ST MESH IN PLACE AND DOES NOT FEEL THE PATIENT¿S CONDITION IS RELATED TO THE PHASIX ST MESH, THEY FEEL IT IS MORE RELATED TO THE PATIENT¿S PREVIOUS CONDITIONS.

  Patient problems: Abscess; Drug Resistant Bacterial Infection

  MAUDE report 18309282 ↗
• MalfunctionNov 15, 2023Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING ROBOTIC ABDOMINAL HERNIA REPAIR PROCEDURE, CUSTOMER REPORTS USING THE PHASIX ST MESH PAST ITS LABELED EXPIRATION DATE. THE LABELED EXPIRATION DATE OF MESH WAS 28-SEP-2023 AND THE PATIENT WAS IMPLANTED WITH THE MESH ON (B)(6) 2023. DURING RISK MANAGEMENT REVIEW, IT WAS NOTICED THAT THE MESH HAD BEEN IMPLANTED BEYOND THE LABELED EXPIRATION DATE. NO INTERVENTION WAS REPORTED, MESH REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18143061 ↗
• InjuryAug 3, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ABOUT 2 WEEKS POST IMPLANT OF A PHASIX ST MESH USED IN A ROBOTIC VENTRAL HERNIA REPAIR AS INTRAPERITONEAL ONLAY, THE PATIENT PRESENTED WITH AN ABDOMINAL RASH AND SKIN LESIONS. AS REPORTED, THE SURGEON DID NOT TREAT THE PATIENT; HOWEVER, THE PATIENT HAD BEEN APPLYING OVER THE COUNTER RASH CREAM AND REPORTED SOME IMPROVEMENT. AS REPORTED, THE SURGEON WILL BE FOLLOWING UP ON PATIENT IN ANOTHER MONTH, AT THIS TIME DECIDED TO CONTINUE TO MONITOR THE PATIENT WITH NO ADDITIONAL TREATMENT. SURGEON ALSO STATES THE PATIENT REPORTS HAVING DIARRHEA, BUT IS UNSURE OF MESH CONNECTION. NOTE, PRIOR TO MESH IMPLANT THE PATIENT HAS A HISTORY OF POST SURGICAL SKIN RASH AND LESIONS.

  Patient problems: Diarrhea; Localized Skin Lesion; Rash

  MAUDE report 17449656 ↗
• InjuryJul 1, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN EXPLORATORY LAPAROTOMY PROCEDURE ON (B)(6) 2021, THE PATIENT UNDERWENT DRAINAGE OF FLUID COLLECTION, REMOVAL OF UNSPECIFIED SYNTHETIC PERMANENT MESH AND A VENTRAL HERNIA REPAIR, DURING WHICH A BARD/DAVOL PHASIX ST MESH WAS IMPLANTED. AS REPORTED, THE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY, CHOLANGIOGRAM AND LYSIS OF ADHESIONS ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT UNDERWENT ANOTHER EXPLORATORY LAPAROTOMY PROCEDURE ON (B)(6) 2022, DURING WHICH SOME OF THE MESH WAS REMOVED FROM AN ABDOMINAL WOUND ALONG WITH LYSIS OF ADHESIONS AND SMALL BOWEL STRICTUREPLASTY.

  Patient problems: Adhesion(s)

  MAUDE report 14885909 ↗
• InjuryMay 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2016 - SUBJECT PATIENT UNDERWENT AN OPEN MULTIPLE RECURRENT VENTRAL SUBXIPHOID/EPIGASTRIC HERNIA REPAIR PROCEDURE USING A BARD/DAVOL PHASIX ST MESH PLACED IN UNDERLAY FASHION FIXATED WITH SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES AND ADHESIVE SKIN CLOSURE. THE SUBJECT PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2016. (B)(6) 2017 - SUBJECT PATIENT WAS DIAGNOSED WITH MESH EXPOSURE WHICH WAS SHARPLY DEBRIDED AT BEDSIDE. THE SURROUNDING AREA WAS TOO THIN FOR SUTURES, THE PATIENT WAS ADVISED TO PACK THE WOUND WITH MOIST-TO-DRY DRESSINGS AND FOLLOW UP IN 6-12 MONTHS. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RESOLVED. (B)(6) 2017 - SUBJECT PATIENT PRESENTED WITH LAXITY AROUND OPENING WITH NO SIGNS OF HERNIA RECURRENCE. (B)(6) 2018 - SURGEON WAS UNABLE TO DETERMINE IF THE CAUSE OF LAXITY WAS DIASTASIS OR THE PATIENT¿S UNDERLAY REPAIR OF ASYMPTOMATIC REDUCIBLE VENTRAL HERNIA. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD IN SEVERITY, POSSIBLY R

  Patient problems: Hernia

  MAUDE report 14496576 ↗
• InjuryMay 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2016 - SUBJECT PATIENT UNDERWENT AN OPEN MULTIPLE RECURRENT VENTRAL SUBXIPHOID/EPIGASTRIC HERNIA REPAIR PROCEDURE USING A BARD/DAVOL PHASIX ST MESH PLACED IN UNDERLAY FASHION FIXATED WITH SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES AND ADHESIVE SKIN CLOSURE. THE SUBJECT PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2016. (B)(6) 2017 - SUBJECT PATIENT WAS DIAGNOSED WITH MESH EXPOSURE WHICH WAS SHARPLY DEBRIDED AT BEDSIDE. THE SURROUNDING AREA WAS TOO THIN FOR SUTURES, THE PATIENT WAS ADVISED TO PACK THE WOUND WITH MOIST-TO-DRY DRESSINGS AND FOLLOW UP IN 6-12 MONTHS. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RESOLVED. (B)(6) 2017 - SUBJECT PATIENT PRESENTED WITH LAXITY AROUND OPENING WITH NO SIGNS OF HERNIA RECURRENCE. (B)(6) 2018 - SURGEON WAS UNABLE TO DETERMINE IF THE CAUSE OF LAXITY WAS DIASTASIS OR THE PATIENT¿S UNDERLAY REPAIR OF ASYMPTOMATIC REDUCIBLE VENTRAL HERNIA. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD IN SEVERITY, POSSIBLY R

  Patient problems: Impaired Healing

  MAUDE report 14496432 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2018 - SUBJECT PATIENT UNDERWENT A ROBOTIC-ASSISTED MULTIPLE RECURRENT MIDLINE VENTRAL HERNIA (12 CM X 13 CM) REPAIR PROCEDURE. SWISS CHEESE CONFIGURATION NOTED. A BARD/DAVOL PHASIX ST MESH WAS PLACED MIDLINE IN AN UNDERLAY FASHION AND FIXATED USING SUTURES. COMPLETE FASCIA CLOSURE COULD NOT BE ACHIEVED DUE TO POOR QUALITY FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING ADHESIVE SKIN CLOSURE AND THE SUBJECT PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2018. (B)(6) 2018 - SUBJECT PATIENT PRESENTED WITH WORSENING ABDOMINAL PAIN AND TENDERNESS AT THE ILEO CONDUIT URETEROSTOMY SITE. SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS DIAGNOSED WITH ABDOMINAL WALL CELLULITIS AT THE SITE. (B)(6) 2018 - SUBJECT PATIENT WAS DIAGNOSED WITH SEPSIS. SUBJECT PATIENT UNDERWENT INCISION AND DRAINAGE AT BED SIDE, UROSTOMY BAG REPLACED TO DECREASE LEAKING AND PATIENT WAS TREATED WITH IV ANTIBIOTICS. THE SUBJECT PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2018. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT OF ABDOMINAL WALL CELLULITIS IS ASSESSED TO BE MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE.

  Patient problems: Abscess

  MAUDE report 14489471 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL DVL-HE-020: ON (B)(6) 2018, SUBJECT PATIENT UNDERWENT A ROBOTIC-ASSISTED MULTIPLE RECURRENT MIDLINE VENTRAL HERNIA (12 CM X 13 CM) REPAIR PROCEDURE. SWISS CHEESE CONFIGURATION NOTED. A BARD/DAVOL PHASIX ST MESH WAS PLACED MIDLINE IN AN UNDERLAY FASHION AND FIXATED USING SUTURES. COMPLETE FASCIA CLOSURE COULD NOT BE ACHIEVED DUE TO POOR QUALITY FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING ADHESIVE SKIN CLOSURE AND THE SUBJECT PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2018. ON (B)(6) 2018, SUBJECT PATIENT PRESENTED WITH WORSENING ABDOMINAL PAIN AND TENDERNESS AT THE ILEO CONDUIT URETEROSTOMY SITE. SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS DIAGNOSED WITH ABDOMINAL WALL CELLULITIS AT THE SITE. ON (B)(6) 2018, SUBJECT PATIENT WAS DIAGNOSED WITH SEPSIS. SUBJECT PATIENT UNDERWENT INCISION AND DRAINAGE AT BED SIDE, UROSTOMY BAG REPLACED TO DECREASE LEAKING AND PATIENT WAS TREATED WITH IV ANTIBIOTICS. THE SUBJECT PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2018. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT OF ABDOMINAL WALL CELLULITIS IS ASSESSED TO BE MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX

  Patient problems: Abdominal Pain; Cellulitis; Sepsis

  MAUDE report 14489455 ↗
• InjuryMay 24, 2022Material Disintegration; Material Disintegration

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017 - SUBJECT PATIENT UNDERWENT ROBOTIC ASSISTED TECHNIQUE FOR FIRST TIME RECURRENT INCISIONAL UMBILICAL HERNIA REPAIR PROCEDURE. THE SIZE OF HERNIA DEFECT WAS 2.1CM X 2.2CM. A BARD/DAVOL PHASIX ST MESH WAS PLACED IN AN UNDERLAY FASHION INTRA-PERITONEALLY WITH SUTURES. FACIA AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES AND ADHESIVE SKIN CLOSURE. ON (B)(6) 2017 - SUBJECT PATIENT DIAGNOSED WITH POST OPERATIVE ILEUS WITH NAUSEA/VOMITING AND PLACED WITH NASOGASTRIC (NG) TUBING FOR DECOMPRESSION AND THE PATIENT DIET WAS ADVANCED SLOWLY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017. 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. ON (B)(6) 2018 ¿ SUBJECT PATIENT UNDERWENT PHYSICAL EXAMINATION AND WAS DIAGNOSED WITH A HERNIA RECURRENCE. ON (B)(6) 2019 - SUBJECT PATIENT UNDERWENT RECURRENT INCISIONAL UMBILICAL HERNIA REPAIR PROCEDURE. REPORTEDLY, THE MESH WAS FOUND TO DISINTEGRATE DURING THE ADHESIONS REMOVAL FROM THE ANTERIOR ABDOMINAL W

  Patient problems: Adhesion(s); Hernia

  MAUDE report 14488233 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2017 - SUBJECT PATIENT UNDERWENT ROBOTIC ASSISTED TECHNIQUE FOR FIRST TIME RECURRENT INCISIONAL UMBILICAL HERNIA REPAIR PROCEDURE. THE SIZE OF HERNIA DEFECT WAS 2.1CM X 2.2CM. A BARD/DAVOL PHASIX ST MESH WAS PLACED IN AN UNDERLAY FASHION INTRA-PERITONEALLY WITH SUTURES. FACIA AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES AND ADHESIVE SKIN CLOSURE. (B)(6) 2017 - SUBJECT PATIENT DIAGNOSED WITH POST OPERATIVE ILEUS WITH NAUSEA/VOMITING AND PLACED WITH NASOGASTRIC (NG) TUBING FOR DECOMPRESSION AND THE PATIENT DIET WAS ADVANCED SLOWLY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017. 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 UNDERWENT PHYSICAL EXAMINATION AND WAS DIAGNOSED WITH A HERNIA RECURRENCE. (B)(6) 2019 - SUBJECT PATIENT UNDERWENT RECURRENT INCISIONAL UMBILICAL HERNIA REPAIR PROCEDURE. REPORTEDLY, THE MESH WAS FOUND TO DISINTEGRATE DURING THE ADHESIONS REMOVAL FROM THE ANTERIOR ABDOMINAL WALL. THE MES

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 14488096 ↗
• 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 12286803 ↗
• InjuryAug 5, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2004, THE PATIENT WAS DIAGNOSED WITH A VENTRAL UMBILICAL HERNIA AND UNDERWENT REPAIR WITH IMPLANT OF A BARD/DAVOL COMPOSIX KUGEL MESH (DEVICE 1). (B)(6) 2016, THE PATIENT HAD AN OFFICE VISIT WITH COMPLAINTS OF A BULGE DEVELOPING IN THE MIDLINE OF THE ABD. A BULGE HAD BEEN THERE FOR YEARS AND GETTING BIGGER WITH TIME WITH SOME PAIN. PATIENT WAS DIAGNOSED WITH AN INCISIONAL HERNIA. (B)(6) 2016, THE PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND UNDERWENT A DIAGNOSTIC LAPAROSCOPY CONVERTED TO EXPLORATORY LAPAROSCOPY WITH SMALL BOWEL RESECTION, RIGHT AND LEFT MYOFASCIAL ADVANCEMENT FLAPS, REPAIR RECURRENT INCISIONAL HERNIA WITH IMPLANT OF A BARD/DAVOL PHASIX MESH (DEVICE 2) AND REMOVAL OF THE OLD COMPOSIX KUGEL MESH (DEVICE 1). PER THE OPERATIVE REPORT DETAILS, "THERE WAS A GREAT DEAL OF SCAR TISSUE PARTICULARLY RIGHT IN THE MIDLINE AT THE OLD MESH (DEVICE 1), SMALL BOWEL WAS ADHERENT TO THE MESH (DEVICE 1). IT APPEARED THAT THE MESH HAD ACTUALLY FOLDED ON ITSELF AND THE SMALL BOWEL WAS ACTUALLY GROWN INTO MESH. HOWEVER, WHERE THE SMALL BOWEL WAS ATTACHED TO THE MESH HAD COMPLETELY GROWN IN

  Patient problems: Hernia

  MAUDE report 8859066 ↗
• InjuryApr 15, 2019Insufficient 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. (B)(6) 2017 - THE SUBJECT PATIENT UNDERWENT A LAPAROSCOPIC UMBILICAL REPAIR OF HERNIA USING AN INTRA-ABDOMINAL APPROACH, WITH IMPLANT OF THE 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. BOTH MECHANICAL AND SUTURE FIXATION WERE USED TO SECURE THE MESH. (B)(6) 2019 - THE SUBJECT PATIENT UNDERWENT A PHYSICAL EXAM IN WHICH A BULGE AT THE UMBILICUS WAS IDENTIFIED. (B)(6) 2019 - THE SUBJECT PATIENT UNDERWENT A CT SCAN THAT CONFIRMED THE BULGE TO BE A HERNIA RECURRENCE. THIS HERNIA RECURRENCE HAS BEEN ASSESSED PER THE CLINICIAN AS MILD IN SEVERITY AND "POSSIBLY RELATED" TO THE STUDY DEVICE AND "POSSIBLY RELATED" TO THE INDEX PROCEDURE. NO ACTION HAS BEEN TAKEN AT THIS TIME, HOWEVER, AS REPORTED, THE SUBJECT WILL BE SCHEDULING AN APPOINTMENT FOR SURGERY IN THE NEAR FUTURE.

  Patient problems: Hernia

  MAUDE report 8515355 ↗