VENTRALIGHT 5954124Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741031601), received between May 18, 2018 and Sep 18, 2024 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (13 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE ADHESIONS WERE REMOVED AND THE SMALL BOWEL AND RIGHT COLON PLACED BACK INTO THE PERITONEAL CAVITY. THE OLD MESH WAS REMOVED AND A GORE-TEX PATCH (VENTRIO MESH - DEVICE #1) WAS USED. THE MESH WAS PLACED INTRAPERITONEAL AND THEN SECURED WITH SUTURES ATTACHING IT TO THE MESH ANTERIORLY AND CIRCUMFERENTIALLY.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA AND SPIGELIAN HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿LEFT LOWER QUADRANT LYSIS OF ADHESIONS WERE ACCOMPLISHED. DISSECTION WAS CARRIED SUPERIORLY, THE ADHESIONS FROM THE PREVIOUS MESH WERE QUITE LARGE AND REVEALED THE RECURRENT HERNIA SUPERIOR TO THE MESH. A PIECE OF VENTRALIGHT ST MESH (DEVICE #2) PLACED IN ELLIPTICAL FASHION AND TACKED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #3) AND PARTIAL REMOVAL OF VENTR

  Patient problems: Abdominal Pain; Abscess; Fistula; Hematoma; Seroma

  MAUDE report 20243652 ↗
• InjuryMay 2, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES MULTIPLE PATIENTS HE REPRESENTS HAVE EXPERIENCE UNSPECIFIED INJURY AND ALLEGE THEY MAY HAVE REQUIRED ADDITIONAL MEDICAL/SURGICAL TREATMENT. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH A XENMATRIX (DEVICE #1) AND VENTRALIGHT ST (DEVICE #2). CASE-SPECIFIC DETAILS NOT PROVIDED. THIS FILE REPRESENTS DEVICE#2 (VENTRALIGHT ST). ADDENDUM PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: 15-OCT-2015 - PATIENT WITH COMPLEX MEDICAL/SURGICAL HISTORY WAS DIAGNOSED WITH MULTIPLE INCISIONAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF XENMATRIX MESH (DEVICE #1). PER OPERATIVE NOTE, "OLD MESH AND ADHESIONS WERE TAKEN DOWN. ENTEROTOMY WAS PERFORMED AND A XENMATRIX MESH WAS TRIMMED TO REPAIR SMALL DEFECT. FURTHER, MESH WAS TRIMMED, USED TO BRIDGE MAIN DEFECT AND SUTURED IN PLACE." (B)(6) 2015 - DURING VISITS DUE TO NATIVE ABDOMINAL WALL OF COMPLEX SURGERIES PATIENT HAD THE WOUND DEHISCED POST OPERATIVELY LEAVING THE MESH EXPOSED THEREBY WOUND REOPENED, REMOVED RESIDUAL OLD SYNTHETIC MESH PIECES, AND CLOSED THE DEFECT WITH THE BRIDGING BIOLOGICAL XENMATRIX MESH (DEVICE #1). (B)(6) 2016 - DURING MULTIPLE VISITS PATIENT HAD THE WOUND DEHISCED, PAIN, RECURRENT HERNIAS WHICH W

  Patient problems: Hernia; Insufficient Information; Scar Tissue

  MAUDE report 19227670 ↗
• InjuryNov 21, 2023Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST. 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: Adhesion(s); Hernia; Insufficient Information; Scar Tissue

  MAUDE report 18183860 ↗
• InjuryFeb 22, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A VENTRAL PLASTY AND CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2022, A 15X15 CM POST INCISIONAL VENTRAL HERNIA WAS FOUND AND THE PATIENT WAS IMPLANTED WITH PREPERITONEAL VENTRALIGHT ST MESH. ON (B)(6) 2022, THE PATIENT PRESENTED WITH SECRETION OF FOOD CONTENT FROM A GASTROSTOMY WOUND, AS WELL AS PAIN IN THE LEFT FLANK, FOLLOWED BY NAUSEA AND VOMITING OF GASTRIC CONTENT ON 5 OCCASIONS, AND PRESENCE OF TACHYCARDIA. ON (B)(6) 2023, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE WITH PLACEMENT OF A NEGATIVE PRESSURE SYSTEM IN THE SURGICAL INJURY AND THE VENTRALIGHT ST MESH WAS REMOVED. AS REPORTED, AT THE TIME OF THE SURGERY THE VENTRALIGHT ST MESH WAS POORLY ADHERED TO THE ABDOMINAL WALL, WITH ABUNDANT CLOUDY BILE SECRETION NOTED, PURULENT FIBRIN PATCHES IN THE UPPER REGION OF THE PREPERITONEAL INJURY.

  Patient problems: Bowel Perforation; Purulent Discharge

  MAUDE report 16418516 ↗
• InjuryJan 31, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE: "FEASIBILITY OF USING A TAILORED MESH IN LAPAROSCOPIC SUGARBAKER PARASTOMAL HERNIA REPAIR". BACKGROUND: IN PARASTOMAL HERNIA (PH) REPAIR LAPAROSCOPIC SUGARBAKER TECHNIQUE (LS) IS CONSIDERED THE BEST PRACTICE; HOWEVER, MESHES SPECIFIC FOR LS REPAIRS CEASED TO BE AVAILABLE. PURPOSE: THE AIM OF THE STUDY WAS TO EVALUATE FEASIBILITY OF USING A PHYSICIAN MODIFIED MESH (TAILORED MESH, VENTRALIGHT ST MESH) IN LAPAROSCOPIC SUGARBAKER TECHNIQUE. CONCLUSION: IN LAPAROSCOPIC SUGARBAKER TECHNIQUE TAILORED MESH (VENTRALIGHT ST MESH) SEEMS TO BE A FEASIBLE MESH COMPARABLE TO SPECIFIC PARASTOMAL MESH (NON-BARD MESH) WITHIN SHORT- AND MID-TERM FOLLOW-UP. ARTICLE STATES ONE PATIENT TREATED WITH VENTRALIGHT ST MESH FOR A LARGE DEFECT EXPERIENCED MESH ¿BULGING¿ 1-YEAR POSTOPERATIVELY, AS SEEN ON IMAGING. PER ARTICLE, BULGING COMMONLY DEVELOPS FOLLOWING STANDARD IPOM REPAIRS OF LARGE SIZE HERNIAS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16272254 ↗
• InjuryJan 27, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE, HEMIPELVECTOMY HERNIA: CASE SERIES AND LITERATURE REVIEW. ABSTRACT PURPOSE: HEMIPELVECTOMY IS A MAJOR OPERATION IN WHICH SIGNIFICANT PORTIONS OF THE PELVIC GIRDLE AND LOWER EXTREMITY ARE RESECTED. THE DEVELOPMENT OF HERNIA FOLLOWING HEMIPELVECTOMY IS A COMPLEX SURGICAL CHALLENGE WITH LIMITED PUBLISHED GUIDELINES FOR MANAGEMENT. CONCLUSION: HERNIA IN THE SETTING OF HEMIPELVECTOMY IS AN INFREQUENTLY REPORTED PROBLEM. GENERAL PRINCIPLES IN MANAGEMENT ARE SIMILAR TO ALL HERNIA REPAIRS AND INCLUDE LOCAL APPROXIMATION OF TISSUES AVOIDANCE OF CONTAMINATION OR WOUND INFECTION AND USE OF PROSTHETIC MESH WHEN LOCAL TISSUE IS INADEQUATE FOR A TENSION-FREE REPAIR. A 46-YEAR-OLD MALE PATIENT UNDERWENT HERNIA REPAIR 3 YEARS AFTER INITIAL HEMIPELVECTOMY. A 34 × 30 CM VENTRALIGHT ST MESH WAS SECURED IN THE PRE-PERITONEAL SPACE TO THE BONE ANCHORS AS WELL AS TO COOPER¿S LIGAMENT AND THE PUBIC TUBERCLE. THE PATIENT DID WELL FOLLOWING SURGERY. A SMALL SEROMA WAS NOTED 2 MONTHS POST-OPERATIVELY. THE SEROMA WAS ASYMPTOMATIC, AND NO MEDICAL/SURGICAL INTERVENTION IDENTIFIED. THE PATIENT ULTIMATELY PASSED AWAY FROM HYPOXIC RESPIRATORY FAILURE BELIEVED TO BE FROM PROGRESSION OF METASTA

  Patient problems: Seroma

  MAUDE report 16252587 ↗
• InjuryDec 1, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2013 AND 3DMAX MESH ON (B)(6) 2019 . AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT 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: Abdominal Pain; Adhesion(s); Hernia; Insufficient Information; Seroma

  MAUDE report 15892887 ↗
• InjuryMay 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2015 - SUBJECT PATIENT UNDERWENT AN OPEN MULTIPLE-RECURRENT LEFT VENTRAL INCISIONAL HERNIA REPAIR PROCEDURE USING A BARD/DAVOL VENTRALIGHT ST MESH WHICH WAS IMPLANTED USING TRANSFASCIAL SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES AND SUTURES. THE HERNIA SITE WOUND WAS CLASS-II CLEAN-CONTAMINATED (STAPHYLOCOCCUS AUREUS). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. (B)(6) 2015 - SUBJECT PATIENT PRESENTED AND WAS ADMITTED WITH FEVER, MALAISE, ABDOMINAL PAIN, ELEVATED WBC AND WAS DIAGNOSED WITH SURGICAL SITE INFECTION (SSI). CULTURE OF J/P DRAINS WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS AND THE PATIENT WAS TREATED WITH IV AND ORAL ANTIBIOTICS. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. (B)(6) 2015 - SUBJECT PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION (SSI) AND WAS TREATED WITH ORAL ANTIBIOTICS. (B)(6) 2015 - SUBJECT PATIENT WAS DIAGNOSED WITH SKIN TISSUE NECROSIS; 2 WOUNDS TO THE RUQ NOTED, 1 WOUND HAD ESCHAR TISSUE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND ANTIBIOTIC OINTMENT. ON FOLLOW-UP, WOUND WAS LARGER W/ INCREASING PAIN AND DRAINING. (B)(6) 2015 - SUBJECT PATIENT WAS HOSPITALIZED FOR INTRAVENOUS (IV)

  Patient problems: Abdominal Pain; Bacterial Infection; Necrosis

  MAUDE report 14498504 ↗
• InjuryMay 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2015 - SUBJECT PATIENT UNDERWENT AN OPEN MULTIPLE-RECURRENT LEFT VENTRAL INCISIONAL HERNIA REPAIR PROCEDURE USING A BARD/DAVOL VENTRALIGHT ST MESH WHICH WAS IMPLANTED USING TRANSFASCIAL SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES AND SUTURES. THE HERNIA SITE WOUND WAS CLASS-II CLEAN-CONTAMINATED (STAPHYLOCOCCUS AUREUS). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. (B)(6) 2015 - SUBJECT PATIENT PRESENTED AND WAS ADMITTED WITH FEVER, MALAISE, ABDOMINAL PAIN, ELEVATED WBC AND WAS DIAGNOSED WITH SURGICAL SITE INFECTION (SSI). CULTURE OF J/P DRAINS WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS AND THE PATIENT WAS TREATED WITH IV AND ORAL ANTIBIOTICS. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. (B)(6) 2015 - SUBJECT PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION (SSI) AND WAS TREATED WITH ORAL ANTIBIOTICS. (B)(6) 2015 - SUBJECT PATIENT WAS DIAGNOSED WITH SKIN TISSUE NECROSIS; 2 WOUNDS TO THE RUQ NOTED, 1 WOUND HAD ESCHAR TISSUE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND ANTIBIOTIC OINTMENT. ON FOLLOW-UP, WOUND WAS LARGER W/ INCREASING PAIN AND DRAINING. (B)(6) -2015 - SUBJECT PATIENT WAS HOSPITALIZED FOR INTRAVENOUS (IV)

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 14498297 ↗
• InjuryMay 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2013 - SUBJECT PATIENT UNDERWENT A FIRST TIME RECURRENT RIGHT FLANK OPEN HERNIA REPAIR USING A BARD/DAVOL VENTRALIGHT ST MESH, FIXATED USING A SORBAFIX FIXATION DEVICE AND SUTURES. THE FASCIA WAS COMPLETELY CLOSED BY RUNNING STITCHES AND FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. (B)(6) 2016 - DURING A PHYSICAL EXAM, THE SUBJECT PATIENT WAS DIAGNOSED WITH RIGHT LUMBAR HERNIA. PATIENT WAS GIVEN TIME TO LOSE WEIGHT. (B)(6) 2017 - CT SCAN PERFORMED HERNIA (10 CM WIDTH). (B)(6) 2017 - SUBJECT PATIENT UNDERWENT HYBRID SURGERY (OPEN AND ROBOTIC) WHEREIN A NON BARD/DAVOL ONLAY MESH WAS PLACED AND THE RECURRENT RIGHT VENTRAL INCISIONAL HERNIA (15 X 15 CM) WAS REPAIRED. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Hernia

  MAUDE report 14438228 ↗
• InjuryMay 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2013 - SUBJECT PATIENT UNDERWENT OPEN LOWER ABDOMEN INCISIONAL HERNIA (20X30 CM) REPAIR AND WAS IMPLANTED WITH A BARD/DAVOL VENTRALIGHT ST MESH PLACED USING MECHANICAL FIXATION AND SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES AND SUTURES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. (B)(6) 2014 - SUBJECT PATIENT PRESENTED WITH ABDOMINAL PAIN AND FULLNESS; HERNIA RECURRENCE NOTED DURING ASSESSMENT (B)(6) 2014 - CT SCAN PERFORMED, PATIENT WAS DIAGNOSED WITH MIDLINE EPIGASTRIC RECURRENT INCISIONAL HERNIA (6X10 CM) ABOVE MESH. (B)(6) 2014 - SUBJECT PATIENT UNDERWENT LAPAROSCOPIC HERNIA REPAIR USING VENTRALIGHT ST MESH W/ECHO PS. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Hernia

  MAUDE report 14438174 ↗
• MalfunctionMay 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018: SUBJECT PATIENT UNDERWENT A PRIMARY MIDLINE OPEN HERNIA (20X30 CM) REPAIR PROCEDURE AND WAS IMPLANTED WITH A BARD/DAVOL VENTRALIGHT ST MESH. THE FASCIA WAS COMPLETELY CLOSED AND FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES AND SUTURES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. ON (B)(6) 2018: SUBJECT PATIENT WAS DIAGNOSED WITH SEROMA. NO TREATMENT GIVEN. BY THE NEXT APPOINTMENT ON (B)(6) 2018, THE SEROMA WAS NO LONGER NOTED. 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 INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Seroma

  MAUDE report 14437998 ↗
• InjuryFeb 25, 2021Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. 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: Hematoma; Hernia; Injury; Seroma

  MAUDE report 11377066 ↗
• InjuryDec 16, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (X2) ON (B)(6) 2019 AND (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Injury; Pain

  MAUDE report 11017639 ↗
• InjuryJul 1, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. IT IS ALLEGED 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: Abdominal Pain; Adhesion(s); Injury; Necrosis; Obstruction/Occlusion

  MAUDE report 10216472 ↗
• InjuryApr 21, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (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: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 9980204 ↗
• InjuryApr 15, 2020Defective 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 VENTRALEX ST AND VENTRALIGHT ST ON (B)(6) 2013 AND/OR (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2014 AND/OR (B)(6) 2016. ATTORNEY ALSO ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE, PERMANENT PERSONAL INJURIES." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST (DEVICE #1). PER OP NOTES, ¿THREE PIECES OF MESHES WERE REMOVED. PLACED A VENTRALIGHT ST MESH (DEVICE #1) IN THE RETRORECTUS SPACE.¿ (NOTE: UNKNOWN MESHES WERE REMOVED DURING THIS PROCEDURE). (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #2). PER OP NOTES, ¿TAKEN DOWN THE ADHESIONS BET

  Patient problems: Abdominal Pain; Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 9966132 ↗
• InjuryJun 25, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE #1) ON (B)(6) 2015 AND AN UNSPECIFIED VENTRALIGHT ST (DEVICE #2) ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO (2) VENTRALIGHT ST (DEVICE #1) AND (DEVICE #2). AS REPORTED, THE 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."

  Patient problems: Disability; Injury; Pain

  MAUDE report 8732716 ↗
• InjuryApr 8, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT ON (B)(6) 2010, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED NON-BARD/DAVOL DULEX MESH. IT IS ALLEGED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE #1). AS ALLEGED, THE PATIENT HAD UNSPECIFIED INJURIES ON (B)(6) 2017. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST (DEVICE #1). AS REPORTED, THE 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."

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain; Scar Tissue

  MAUDE report 8493019 ↗
• InjuryMay 18, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2015 - PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR A BARD/DAVOL "VENTRALIGHT ST BARD MESH" WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2015 - PATIENT UNDERWENT RELEASE OF A SMALL-BOWEL OBSTRUCTION AND REMOVAL OF THE FAILED VENTRALIGHT ST. UPON EXPLORATION OF THE PATIENT'S ABDOMEN, THE DOCTOR NOTED "THERE WAS A LOOP OF SMALL BOWEL THAT WAS ADHERENT TO THE CORNER OF THE MESH IN THE RIGHT LATERAL ABDOMINAL WALL. THE ABDOMINAL MESH WAS ENTIRELY REMOVED." AS REPORTED THE PATIENT'S ATTORNEY ALLEGES THAT THE VENTRALIGHT ST "HAD TO BE REMOVED VIA INVASIVE SURGERY AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA" AND THAT "THE PATIENT HAS BEEN INJURED AND SUSTAINED SEVERE PAIN AND SUFFERING, DISABILITY AND IMPAIRMENT."

  Patient problems: Adhesion(s); Disability; Obstruction/Occlusion

  MAUDE report 7526592 ↗