PhasixRecalls & reported problems across all models
Davol Inc. · 43 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 345
- Deaths reported
- 3
- Injuries reported
- 283
- Recalls
- 0
We found 43 models of Phasix by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 345 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2017 and Sep 22, 2026 — classified as 3 deaths, 283 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (139 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Phasix problems
Device problems
- Patient-Device Incompatibility139
- Patient Device Interaction Problem84
- Insufficient Device Problem Information69
- Defective Device59
- Tear, Rip or Hole in Device Packaging25
- Adverse Event Without Identified Device or Use Problem12
- Expiration Date Error6
- Device Contamination with Chemical or Other Material5
Patient problems
- Hernia110
- No Clinical Signs, Symptoms or Conditions56
- Seroma52
- Adhesion(s)50
- Unspecified Infection45
- Pain37
- Insufficient Information31
- Abscess29
Phasix models
43 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Phasix 1190500surgical film39 reports
- Phasix 1201520Mesh, surgical, polymeric34 reports
- Phasix 1190400surgical film26 reports
- Phasix 1200710Mesh, surgical, polymeric24 reports
- Phasix 1190200surgical film22 reports
- Phasix 1190300surgical film2 deaths20 reports
- Phasix 1191530surgical film19 reports
- Phasix 1201015Mesh, surgical, absorbable, abdominal hernia17 reports
- Phasix 1200015surgical film16 reports
- Phasix 1202025Mesh, surgical, polymeric1 death16 reports
- Phasix 1191025surgical film11 reports
- Phasix 1192040surgical film10 reports
- Phasix 1200011Mesh, surgical, polymeric9 reports
- Phasix 1202530Mesh, surgical, polymeric8 reports
- Phasix 1190820surgical film7 reports
- Phasix 1191020surgical film6 reports
- Phasix 1210011Mesh, surgical, absorbable, abdominal hernia6 reports
- Phasix 1200008Mesh, surgical, polymeric5 reports
- Phasix 1201020Mesh, surgical, polymeric5 reports
- Phasix 1192030surgical film5 reports
- Phasix 1193045surgical film5 reports
- Phasix 1190603surgical film4 reports
- Phasix 1211015Laparoscope, general & plastic surgery4 reports
- Phasix 1190100surgical film3 reports
- Phasix 1201010Mesh, surgical, absorbable, abdominal hernia3 reports
- Phasix 1190600Mesh, surgical, absorbable, abdominal hernia2 reports
- Phasix 1194040surgical film2 reports
- Phasix 1220011surgical film2 reports
- Phasix 1190601Mesh, surgical, absorbable, abdominal hernia1 report
- Phasix 1190602surgical film1 report
- Phasix 1201325Mesh, surgical, absorbable, abdominal hernia1 report
- Phasix 1203035surgical film1 report
- Phasix 1190616surgical film1 report
- Phasix 1193030surgical film1 report
- Phasix 1192540surgical film1 report
- Phasix 1193535surgical film1 report
- Phasix 1210015Mesh, surgical, absorbable, abdominal hernia1 report
- Phasix 1211520Mesh, surgical, polymeric1 report
- Phasix 1212025Mesh, surgical, deployer1 report
- Phasix 1221015Mesh, surgical, polymeric1 report
- Phasix 1221520surgical film1 report
- Phasix 1222530Mesh, surgical, absorbable, abdominal hernia1 report
- Phasix 1230008Mesh, surgical, absorbable, abdominal hernia1 report
Recent Phasix adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Patient-Device Incompatibility
Patient problems: Urticaria
MAUDE report 50860229 ↗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 ↗InjuryAug 26, 2026Patient-Device Incompatibility
Per information provided:(b)(6) 2012 - Patient was diagnosed with recurrent ventral hernia, incarcerated incisional hernia, thereby underwent open repair with explant of synthetic mesh, implant of Ventrio ST Mesh (Device 1). Per op notes, "Through a midline incision, previously placed synthetic mesh was identified and was dissected. Then a midline fascia was identified and repaired by placing a Ventrio ST Mesh (Device 1) into the defect and was sutured." (b)(6) 2013 - Patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with implant of Ventrio ST Mesh (Device 2). Per op notes, "Hernia defect in the abdominal region was identified and was dissected. A Ventrio ST Mesh (Device 2) was placed and secured in place with sutures to the previous mesh (Device 1) in the midline and was tacked to cover the entire defect."(b)(6) 2015 - Patient was diagnosed with recurrent ventral hernia, thereby underwent open repair. Per op notes, "Purulent drainage was noted from the middle portion of the midline incision site."(b)(6) 2016 - Patient was diagnosed with abdominal pain, thereby underwent repair with implant of biologic mesh. Extensive intra-abdominal small bowel
Patient problems: Scar Tissue; Unspecified Infection
MAUDE report 50459855 ↗InjuryAug 26, 2026Patient-Device Incompatibility
As reported, on (b)(6) 2026 during a robotic ventral hernia repair procedure the patient was implanted with Phasix Flat Mesh. As reported, the patient had a post-operative fever and the patient's wife called the surgeon multiple times reporting her concerns. There was no reported treatment provided by the surgeon. In follow up with the surgeon it is reported that, "the patient no longer has a fever and doing well."
Patient problems: Fever
MAUDE report 50456685 ↗InjuryJul 31, 2026Patient-Device Incompatibility; No Apparent Adverse Event
As reported per Clinical Trial (b)(4):The subject patient underwent an open primary exploratory laparotomy with distal pancreatectomy, splenectomy splenic artery lymphadenectomy, omental flap, liver wedge biopsy as concomitant procedures on (b)(6) 2025, during which the patient was implanted with Phasix Mesh onlay was trimmed and implanted using 3-0 PDS absorbable monofilament suture. The midline fascia was completely closed with slow absorbing monofilament 0 PDS sutures using running stitch. Subject was known to have pancreatic leak from POD 3 drain amylase (1781), sent home with JPs to remove later. The subject was discharged from hospital on (b)(6) 2025.(b)(6) 2026 - The patient was diagnosed with an incisional hernia occurrence. During the 12-month follow-up visit, the Sub-I palpated a 5 x 5 cm hernia on physical examination.As reported, the adverse event (Incisional Hernia Occurrence) has been assessed per clinician (medical monitor) as probably related to the study device, causally related to the procedure and not recovered/not 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 does not mee
Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions
MAUDE report 50103761 ↗InjuryJul 30, 2026Patient-Device Incompatibility
Per information provided:(b)(6) 2018- Patient was diagnosed with left incarcerated inguinal hernia thereby underwent laparoscopic repair with implant of 3DMax Mesh (Device 1). Per op notes, "In right inguinal region, no hernia was noted. In left inguinal region, hernia was identified and dissected. A 3DMax Mesh (Device 1) was placed covering the hernia defect into the preperitoneal space and was sutured." (b)(6) 2019- Patient was diagnosed with incisional hernia, thereby underwent open repair with implant of Ventrio ST Mesh (Device 2). Per op notes, "Through upper midline epigastric incision, hernia defect was identified and was dissected. An extra-large Ventrio ST Mesh (Device 2) was inserted into preperitoneal space and sutured."(b)(6) 2019- Patient was diagnosed with infected mesh, incisional hernia, thereby underwent open repair with explant of Ventrio ST Mesh (Device 2), implant of Phasix ST Mesh (Device 3). Per op notes, "Hernia developed seroma and penetrated the Ventrio ST Mesh (Device 2) and this mesh was excised. A Phasix ST Mesh (Device 3) was placed in the preperitoneal space and was sutured."(b)(6) 2019- Patient was diagnosed with recurrent incisional hernia, thereby u
Patient problems: Adhesion(s); Hernia; Scar Tissue
MAUDE report 50091023 ↗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 ↗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 ↗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 ↗InjuryJun 16, 2026Use of Device Problem
AS REPORTED ON (B)(6) 2026, THE PATIENT WAS IMPLANTED WITH A PHASIX MESH. AS REPORTED, THE MESH WAS USED IN AN "INFECTED HERNIA CASE." REPORTEDLY, TWO (2) MONTHS POST IMPLANTATION THE PHASIX MESH WAS REMOVED DUE TO SEVERE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25525225 ↗InjuryMay 29, 2026Patient-Device Incompatibility
PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "INCISION WAS MADE AROUND THE UMBILICAL REGION. A PERFIX PLUG AND PATCH (DEVICE 1) WAS PLACED INTO THE DEFECT USING PROLENE SUTURES." (B)(6) 2012 - PATIENT HAD PARTIAL SMALL BOWEL OBSTRUCTION AND ABDOMINAL PAIN. (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA AND INFECTED ABDOMINAL WALL MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, "EROSION OF SMALL BOWEL TO MESH AT THE UMBILICUS WITH ENTEROCUTANEOUS FISTULA. LOOP OF BOWEL STUCK UP TO THE BACKSIDE OF IT THAT WAS FISTULIZED TO THE MESH AND THE MESH (DEVICE 1) WAS REMOVED. A PHASIX MESH (DEVICE 2) WAS PLACED INTO THE WOUND." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WOUND INFECTION THEREBY UNDERWENT INCISION AND DRAINAGE OF ABDOMINAL WOUND. PER OP NOTES, "PATIENT HAD A HEMATOMA AND WAS EVACUATED. AT THE BASE OF THE WOUND WAS A PIECE OF MESH (DEVICE 2) THAT WAS SUTURED TO THE PATIENT ABDOMEN."
Patient problems: Hematoma; Wound Infection
MAUDE report 25333464 ↗MalfunctionMay 8, 2026Patient-Device Incompatibility
AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND UNDERWENT AN OPEN PRIMARY LAPAROTOMY, EXPLORATORY LAPAROTOMY AND COLECTOMY DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT SUTURES WITH 2-0 PDS. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH (30 CM LENGTH AND 7 CM WIDTH). THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBING MONOFILAMENT WITH RUNNING STITCHES APPROXIMATELY 1 CM FAR APART AND 63 CM IN LENGTH. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED A SEROMA ON INCISION SITE, NO TREATMENT OR MEDICATION REQUIRED. THE SEROMA IS REPORTED AS RECOVERING AND RESOLVING. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND A PROBABLE RELATIONSHIP TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY AND RECOVERING AND 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 25123101 ↗InjuryApr 10, 2026Patient-Device Incompatibility
AS REPORTED PER CLINICAL TRIAL (B)(6): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND UNDERWENT AN OPEN PRIMARY LAPAROTOMY, COLECTOMY, EXPLORATORY LAPAROTOMY AND SMALL BOWEL RESECTION DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT SUTURES WITH 2-0 PDS. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH (39 CM LENGTH AND 6 CM WIDTH). THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBING MONOFILAMENT WITH RUNNING STITCHES APPROXIMATELY 1 CM FAR APART AND 30 CM IN LENGTH. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED A SMALL SEROMA ON INCISION SITE, NO TREATMENT OR TEST DONE. THE SEROMA WAS RESOLVED ON (B)(6) 2026. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLE RELATED TO THE STUDY DEVICE AND A PROBABLE RELATIONSHIP TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY AND RECOVERED AND RESOLVED; 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 24839738 ↗InjuryApr 1, 2026Patient-Device Incompatibility
PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1) AND VENTRALEX MESH (DEVICE 2). PER OP NOTES, "PREVIOUS INCISION OVER THE PATIENT'S EPIGASTRIC HERNIA, A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED IN THE ABDOMINAL CAVITY USING PROLENE SUTURES. ATTENTION WAS THEN TURNED TO THE UMBILICUS WHERE A SUPRAUMBILICAL INCISION WAS MADE, A VENTRALEX MESH (DEVICE 2) WAS PLACED IN THE DEFECT USING PROLENE SUTURES." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL UMBILICAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2) AND IMPLANT OF PHASIX MESH (DEVICE 3). PER OP NOTES, "PATIENT'S PREVIOUS MIDLINE INCISION WAS EXTENDING TO THE LEVEL OF THE UMBILICUS. THERE WAS A DEFECT PRESENT IN THE FASCIA AS WELL AS MESHOMA, THE PRIOR MESH (DEVICE 1) CONTRACTED INTO A MASS, THIS WAS DISSECTED. THERE WERE OMENTAL ADHESIONS OF THE PTFE SURFACE OF THE MESH, THESE WERE TAKEN DOWN. PALPATED THE AREA OF THE UMBILICUS, THERE WAS THE PREVIOUSLY PLACED UMBILICAL MESH. THIS UMBILICAL MESH (DEVICE 2) WAS ALSO DISSECTED OUT. A PHASIX MESH (DEVICE 3) WA
Patient problems: Hernia
MAUDE report 24756703 ↗InjuryMar 31, 2026Device Appears to Trigger Rejection
PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 1). PER OP NOTES, "THE HERNIA AT THE PREVIOUS INCISION SITE WAS NOTED. A PREPERITONEAL FAT STUCK WITHIN THE HERNIA WAS REDUCED. A ROUND VENTRALIGHT ST USING ECHO PS (DEVICE 1) WAS PLACED INTO ABDOMINAL CAVITY AND PULLED UP TOWARDS THE ANTERIOR ABDOMINAL WALL TO HERNIA USING SUTURES." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, "RECURRENT HERNIA AND EVENTRATION OF THE PREVIOUS MESH (DEVICE 1) WAS NOTED. ADHESIOLYSIS WAS PERFORMED. MYOCUTANEOUS FLAPS WERE RAISED TO BRING THE RECTUS MUSCLES BACK TOWARDS THE MIDLINE TO RESTORE ABDOMINAL WALL FUNCTION AND REDUCE PAIN OF THE MESH PROTRUDING THROUGH AND PUTTING PRESSURE ON THE ANTERIOR ABDOMINAL WALL. A PIECE OF PHASIX MESH (DEVICE 2) WAS PLACED AS AN ONLAY AND SECURED DOWN TO FASCIA USING SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIG
Patient problems: Abdominal Pain; Adhesion(s); Hernia
MAUDE report 24744016 ↗
Other Davol Inc. products
All Davol Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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