BARD 0117016Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00801741030932), received between Mar 29, 2017 and Apr 7, 2026 — classified as 41 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (29 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P WITH ECHO PS (DEVICE 1). PER OP NOTES, ¿A MULTILOBULATED HERNIA SAC WITH THREE DIFFERENT HERNIAS AROUND THE UMBILICUS WAS NOTED. THE HERNIA DEFECT WAS THEN CLOSED BY PLACING SMALL STAB WOUNDS ALONG THE LATERAL LEFT EDGE OF THE HERNIA DEFECT. THE SUTURES WERE PLACED TO CLOSE THE DEFECT IN THE MIDLINE. A COMPOSIX L/P WITH ECHO PS (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURED WITH SUTURE AND PERMAFIX STAPLER TO THE ABDOMINAL WALL.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX L/P WITH ECHO PS (DEVICE 1) AND IMPLANT OF TWO BARD SOFT MESH (DEVICE 2 AND 3). PER OP NOTES, ¿A CURVILINEAR ELLIPTICAL TRANSVERSE INCISION WAS MADE THAT INCLUDED THE HERNIA SAC AND UMBILICAL STALK. THE HERNIA SAC WAS EXCISED. THE PRIOR MESH (DEVICE 1) WAS EXPLANTED. SOME HOLES IN THE PERITONEUM WERE CLOSED WITH SUTURE. TWO LARGE PIECES OF BARD SOFT MESH (DEVICE 2 AND 3) WERE PLACED TO COVER THE CLOSED PERITONEUM AND SECURED WITH SUTURES.¿ ON (B)(6) 2018

  Patient problems: Abscess; Purulent Discharge

  MAUDE report 24802273 ↗
• InjuryApr 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P WITH ECHO PS (DEVICE 1). PER OP NOTES, ¿A MULTILOBULATED HERNIA SAC WITH THREE DIFFERENT HERNIAS AROUND THE UMBILICUS WAS NOTED. THE HERNIA DEFECT WAS THEN CLOSED BY PLACING SMALL STAB WOUNDS ALONG THE LATERAL LEFT EDGE OF THE HERNIA DEFECT. THE SUTURES WERE PLACED TO CLOSE THE DEFECT IN THE MIDLINE. A COMPOSIX L/P WITH ECHO PS (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURED WITH SUTURE AND PERMAFIX STAPLER TO THE ABDOMINAL WALL.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX L/P WITH ECHO PS (DEVICE 1) AND IMPLANT OF TWO BARD SOFT MESH (DEVICE 2 AND 3). PER OP NOTES, ¿A CURVILINEAR ELLIPTICAL TRANSVERSE INCISION WAS MADE THAT INCLUDED THE HERNIA SAC AND UMBILICAL STALK. THE HERNIA SAC WAS EXCISED. THE PRIOR MESH (DEVICE 1) WAS EXPLANTED. SOME HOLES IN THE PERITONEUM WERE CLOSED WITH SUTURE. TWO LARGE PIECES OF BARD SOFT MESH (DEVICE 2 AND 3) WERE PLACED TO COVER THE CLOSED PERITONEUM AND SECURED WITH SUTURES.¿ (B)(6) 2018 - PATIEN

  Patient problems: Abscess; Purulent Discharge

  MAUDE report 24801786 ↗
• InjuryMar 9, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2000 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿AN INFRAUMBILICAL INCISION WAS MADE OVER THE UNDERLYING MASS. A COMPLEX HERNIA WITH MULTIPLE CAVITIES OF HERNIA SAC WITH INCARCERATED OMENTUM WAS IDENTIFIED. SOME OF THE OMENTUM WAS RESECTED. NUMEROUS HOLES IN THE FASCIA CAUSING A LONG DEFECT WERE NOTED AND REPAIRED WITH SUTURES. A BARD FLAT MESH (DEVICE 1) WAS PLACED AND SECURED WITH SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD SOFT MESH (DEVICE 2). PER OP NOTES, ¿PREVIOUS MIDLINE INCISION WAS OPENED. A TRANSVERSE INCISION WAS MADE ABOVE THE GROIN CREASE. THE HERNIA SAC WAS IDENTIFIED AND THE CONTENTS WERE MOVED. THE PREVIOUS MESH HAD TORN LOOSE AND WAS INCORPORATED IN PARTS OF THE HERNIA SAC. THE SCAR OVER THE PREVIOUS MIDLINE INCISION AND ALL THE HERNIA SAC WAS THEN EXCISED. A BARD SOFT MESH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES. A DRAIN WAS PLACED AND THE SKIN WAS CLOSED WITH AN ABSORBABLE STITCHES.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH R

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24543087 ↗
• InjuryMar 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCISIONAL/VENTRAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST (DEVICE 1). PER OP NOTES, ¿EPIGASTRIC AND UMBILICAL HERNIA SACS WERE NOTED WITH SMALL OTHER MULTIPLE HERNIA DEFECTS. ALL THE DEFECTS WERE REDUCED AND DISSECTED FREE. BOTH THE DEFECTS WERE JOINED. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED AND SECURED USING SUTURES.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH LYSIS OF ADHESIONS. PER OP NOTES, ¿MULTIPLE DILATED LOOPS OF SMALL BOWEL AND THE PRIOR MESH (DEVICE 1) ADHERENT TO THE ANTERIOR ABDOMINAL WALL WAS TAKEN DOWN. SOME SEROUS FLUID WAS SUCTIONED OUT. ADHESIONS WERE LYSED. DILATED AND COLLAPSED BOWEL WAS RELEASED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD SOFT MESH (DEVICE 2). PER OP NOTES, ¿SCAR TISSUE WAS EXCISED. LYSIS OF ADHESIONS WERE PERFORMED. ENTEROTOMY WAS MADE, THE BOWEL WAS TRANSECTED. INJURED BOWEL WAS TRANSECTED. THE PRIOR MESH (DEVICE 1) WAS NOTED. THE HERNIA WAS REPAIRED USIN

  Patient problems: Adhesion(s); Fistula; Scar Tissue

  MAUDE report 24504789 ↗
• MalfunctionFeb 12, 2026Device Contamination with Chemical or Other Material

  AS REPORTED, UPON OPENING THE PACKAGE IT WAS NOTED THAT THE SOFT MESH PACKAGE HAD A SMALL BLACK ITEM ON THE MESH. THE DEVICE WAS NOT USED AND ANOTHER MESH WAS OPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326888 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE: "IMPACT OF TRANSVERSUS ABDOMINIS RELEASE (TAR) WITH BOTULINUM TOXIN (BTX) INJECTION VERSUS TAR WITHOUT BTX INJECTION ON QUALITY OF LIFE AND POSTOPERATIVE PAIN IN LARGE VENTRAL HERNIA REPAIR: A COMPARATIVE STUDY" THIS PROSPECTIVE COHORT STUDY INVESTIGATED WHETHER ADJUNCTIVE BOTULINUM TOXIN (BTX) INJECTION IMPROVES OUTCOMES IN PATIENTS UNDERGOING TRANSVERSUS ABDOMINIS RELEASE (TAR) FOR LARGE VENTRAL HERNIA REPAIR. THE STUDY AIMED TO ASSESS POSTOPERATIVE PAIN, INTRA-ABDOMINAL PRESSURE (IAP), QUALITY OF LIFE, AND RECURRENCE RATES, WITH BARD SOFT MESH USED FOR ABDOMINAL WALL REINFORCEMENT. PATIENTS AGED 18 YEARS OR MORE WITH LARGE VENTRAL HERNIAS (DEFECT WIDTH 10 CM OR MORE) WERE INCLUDED. BTX WAS ADMINISTERED FOR DEFECTS MORE THAN 12 CM, SABBAGH'S INDEX 20% OR MORE, OR MILD TO MODERATE PULMONARY COMPROMISE. NINETY-SEVEN PATIENTS WERE ANALYZED (APRIL 2019-JUNE 2023): TAR+BTX GROUP (N-55) AND TAR-ONLY GROUP (N-42). ALL REPAIRS UTILIZED BARD SOFT MESH (30X30 CM) PLACED IN THE RETRO MUSCULAR PLANE. BTX INJECTIONS (200 UNITS BOTOX, ALLERGAN) WERE GIVEN FOUR WEEKS PREOPERATIVELY. OUTCOMES WERE ASSESSED OVER 12 MONTHS USING HERQLES SCORES, IAP MEASUREMENTS, PAIN SCORES, A

  Patient problems: Hematoma; Seroma; Unspecified Infection

  MAUDE report 24018814 ↗
• InjuryDec 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER LEGAL FORM: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BD COMPOSIX KUGEL PATCH AND BARD MESH ON (B)(6) 2008 AND/OR (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX KUGEL PATCH AND BARD MESH. 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. PER INFORMATION PROVIDED: ON (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, ¿A LARGE INCISIONAL HERNIA WAS NOTED. A LARGE COMPOSIX KUGEL PATCH (DEVICE 1) WAS SECURED TO FASCIA AND LAID AGAINST THE POSTERIOR SURFACE OF ABDOMINAL WALL USING SUTURES.¿ ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF BARD SOFT MESH (DEVICE 2). PER OP NOTES, ¿PATIENT HAD EXTENSIVE ADHESI

  Patient problems: Pain

  MAUDE report 23728597 ↗
• InjuryOct 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6)2016 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD SOFT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A PIECE OF BARD SOFT MESH (DEVICE 1) WAS PLACED INTO THE RETRORECTUS SPACE AND SUTURED.¿ (B)(6)2016 ¿ PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND RECURRENT HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 2). PER OPERATIVE NOTES, ¿A VENTRALIGHT ST USING ECHO PS (DEVICE 2) WAS PLACED INTO THE ABDOMEN AND ATTACH IT TO THE ANTERIOR ABDOMINAL WALL AND TACKED.¿ (B)(6)2018 ¿ PATIENT WAS DIAGNOSED WITH MULTIPLY RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿THE RETRORECTUS PIECE OF MESH AND INTRAPERITONEAL MESH WAS NOTED. BOTH PIECES OF MESH WERE CUT IN HALF. ADHESIONS WERE LYSED. THE MESENTERIC BORDER OF THE BOWEL WAS SCARRED. A PIECE OF SYNTHETIC MESH WAS PLACED AND SECURED USING SUTURES.¿

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 23321052 ↗
• InjurySep 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2002 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A COMPOSIX E/X PIECE OF MESH (DEVICE 1) WAS PLACED IN THE SUBUMBILICUS AND SUTURED.¿ (B)(6) 2003 ¿ PATIENT WAS DIAGNOSED WITH LEFT SIDE RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 2) PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS NOTED TO THE LATERAL ATTACHMENT OF THE PREVIOUS MESH (DEVICE 1) TO ABDOMINAL WALL. A COMPOSIX KUGEL MESH (DEVICE 2) WAS PLACED IN THE DEFECT AND TACKED.¿ (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE MEDIAL WALL OF THE DEFECT CONSISTED OF THE PREVIOUSLY PLACED MESH. THE HERNIA SAC WAS REDUCED AND THE PREPERITONEAL POCKET IS CREATED. A COMPOSIX KUGEL MESH (DEVICE 3) WAS PLACED INTO THE POCKET AND CENTERED BENEATH THE DEFECT USING SUTURES.¿ (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH MASS ABDOMINAL WALL THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF MESH (DEVICE 1, 2, 3). PER OPERATIVE NOTES, ¿THERE WA

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

  MAUDE report 23035929 ↗
• InjuryAug 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2002 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OPERATIVE NOTES, ¿THE UMBILICAL HERNIA SAC WAS DISSECTED OFF THE SURROUNDING STRUCTURES AND MEDIUM PERFIX PLUG (DEVICE 1) WAS PLACED AND SUTURED.¿ ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF PREVIOUSLY PLACED MESH (DEVICE 1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿THE OMENTUM WAS ADHERENT TO THE UMBILICAL DEFECT AND MESH (DEVICE 1) WAS SEEN ROLLED AND SCARRED TO EDGE OF THE HERNIA DEFECT. THE HERNIA SAC AND MESH (DEVICE 1) WAS DISSECTED, AND HERNIA DEFECT WAS REPAIRED WITH SYNTHETIC MESH THEN SUTURED AND TACKED.¿ ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF SYNTHETIC MESH AND IMPLANT OF BARD SOFT MESH (DEVICE 2). PER OPERATIVE NOTES, ¿MULTIPLE MIDLINE FASCIAL DEFECTS WERE IDENTIFIED. SEVERAL ADHESIONS OF SMALL BOWEL AND OLD SYNTHETIC MESH. THE SYNTHETIC MESH WITH HEAVY SCAR WAS EXCISED AND FASCIAL DEFECT WAS CLOSED WITH SUTURES. A BARD SOFT MESH (DEVI

  Patient problems: Hernia; Pain

  MAUDE report 22911102 ↗
• MalfunctionAug 14, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED, OPEN INCARCERATED VENTRAL HERNIA REPAIR PROCEDURE WAS PERFORMED ON (B)(6) 2025. DURING THIS PROCEDURE A SOFT MESH WAS PLACED IN CONTACT WITH THE BOWEL, CONTRARY TO THE INSTRUCTIONS-FOR-USE. THE MESH REMAINS IMPLANTED AND AT THIS TIME THERE HAS BEEN NO ADVERSE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802970 ↗
• InjuryJul 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OP NOTES, ¿EXTENSIVE ADHESIONS AROUND THE PREVIOUS SYNTHETIC MESH HAVE BEEN TACTED AS WELL AS SEVERAL HERNIA DEFECTS AROUND THE MESH WERE NOTED. A SEPRAMESH IP (DEVICE #1) WAS PLACED OVER THE MESH THROUGH PERITONEAL CAVITY AND TACKED CIRCUMFERENTIALLY.¿ ON (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH NONHEALING ABDOMINAL WOUND, INFECTED ABDOMINAL MESH THEREBY UNDERWENT PARTIAL REMOVAL OF MESH (DEVICE #1). PER OP NOTES, ¿A LARGE PIECE OF BILE-STAINED SYNTHETIC MESH WITH SOME PURULENT FLUID WAS REMOVED. ABSCESS WERE DRAINED. A SEPRAMESH IP (DEVICE #1) WAS COMPLETELY ADHERENT TO THE BOWEL. AREA OF BOWEL HAD ERODED THROUGH MESH CAUSING ENTEROCUTANEOUS FISTULA. A PIECE OF INFECTED MESH WAS REMOVED AND REST OF MESH KEPT IN PLACE." ON (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH CHRONIC NONHEALING ANTERIOR ABDOMINAL WALL AND ENTEROCUTANEOUS FISTULA ABDOMINAL WALL THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE SKIN GRAFT WAS PLACED OVER THE WOUND BED AND SUCTION WAS KEPT OVER THE FISTULA TO PREVENT SUCCUS SPILLAGE.

  Patient problems: Impaired Healing; Scar Tissue; Seroma

  MAUDE report 22380749 ↗
• InjuryFeb 12, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH THREE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, "THE SCARRED SUBCUTANEOUS ADIPOSE TISSUE TO A LARGE HERNIA SAC WITH TWO HERNIAS WERE NOTED. THE FASCIAL BRIDGE CONNECTING THE HERNIAS WAS OPENED CONVERTING INTO A SINGLE HERNIA. THE FASCIAL EDGES WERE FREED AND ADHERENT OMENTUM WAS TAKEN DOWN. A VENTRALEX PATCH (DEVICE #1) WAS PLACED IN FASCIAL TISSUE PLANE AND SUTURED. ANOTHER FASCIAL DEFECT WAS CLOSED PRIMARILY. THE DEFECT WAS CLOSED ON TOP OF THE PATCH." (B)(6) 2012 - PATIENT HAD SYMPTOMATIC GALL STONES THEREBY UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY. (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT MIDLINE INCISIONAL HERNIA WITH INTRABDOMINAL ADHESIONS AND PARTIAL SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF VENTRALEX (DEVICE #1) AND IMPLANT OF BARD SOFT MESH (DEVICE #2) AND XENMATRIX AB (DEVICE #3). PER OPERATIVE NOTES, "THE PRIOR MESH (DEVICE #1) HAD PULLED LOOSE FROM SURROUNDING FASCIA AND WAS EXCISED. ADHESIONS WERE NOTED TO THE SMALL BOWEL BOTH PROXIMALLY AND DISTALLY, FAIRLY ADH

  Patient problems: Seroma

  MAUDE report 21362608 ↗
• InjuryOct 17, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2020 ¿PATIENT DIAGNOSED WITH SUSPECTED PELVIC PROLAPSE AND URINARY INCONTINENCE AND UNDERWENT A T.V.T TRANSACTIVATOR PROCEDURE (UNKNOWN PRODUCT USED). ON (B)(6) 2021 ¿ PATIENT DIAGNOSED NEUROPATHIC PAIN IN THE VAGINAL SAC AND ROOT OF THE RIGHT THIGH WITH PAINFUL TRIGGER POINT SINCE TOT STRIP INSTALLATION DUE TO PROBABLE INJURY TO THE OBTURATOR NERVE. WE MANAGE TO DISSECT THE ENTIRE VAGINAL PORTION OF THE RIGHT ARM OF THE SLING (UNKNOWN PRODUCT) UP TO THE OBTURATOR MEMBRANE. ON (B)(6) 2022 ¿ TVT SUB-URETHRAL STRIP (UNKNOWN PRODUCT USED)¿ SUBTOTAL HYSTERECTOMY ¿ LEFT ANNEXIECTOMY - ANTERIOR AND POSTERIOR PROMOTION OF FIXATION BY ROBOTIC WAY. PART 1: INSTALLATION OF A TYE TVT SUB-URETHRAL STRIP (UNKNOWN PRODUCT) - CYSTOSCOPY CONFIRMS THE CORRECT POSITIONING OF THE NEEDLES AND THE ABSENCE OF BLADDER PENETRATION OF THE STRIP OR URETHRAL WOUND. THE STRIP IS ADJUSTED BY PROVIDING A SUBURETHRAL GAP OF APPROXIMATELY 5 MM. REMOVAL OF THE SHIRT AND SECTION OF THE ARMS OF THE STRIP AT THE LEVEL OF ITS SUPRAPUBIC EXIT POINTS. PART 2: SUBTOTAL HYSTERECTOMY AND LEFT ANNEXECTOMY AND ANTERIOR PROMONTOFIXATION POST BY ROBOT-ASSISTED COELIOSCOPIC WAY. ¿PLACEMENT OF

  Patient problems: Pain

  MAUDE report 20472623 ↗
• InjuryOct 1, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6)2013 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE SAC WAS INCISED. A SMALL VENTRALEX ST MESH (DEVICE #1) WAS USED INTO THE EXTRAPERITONEAL SPACED AND SUTURED.¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCOMPLETE PRIMARY HEALING AND FLUID ACCUMULATION. ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH WOUND INFECTION THEREBY UNDERWENT WOUND CARE. ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH NON-HEALING UMBILICAL WOUND AND INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF ABSORBABLE MESH AND EXPLANT OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE MESH PRODUCTS AND SUTURES WERE CAREFULLY DISSECTED AND REMOVED. THE RESULTING DEFECT WAS PALPATED. THERE WAS SO ADHERENT SMALL BOWEL. THIS WAS CLOSED WITH A DOUBLE LAYER OF ABSORBABLE MESH AND SUTURED.¿ ON (B)(6) 2013 - PATIENT UNDERWENT HIATAL HERNIA REPAIR THEREBY UNDERWENT PLACEMENT OF AP STANDARD LAP-BAND WITH E2 PORT. PER OPERATIVE NOTES, ¿THE HERNIA DEFECT WAS IDENTIFIED. THE DEFECT WAS CLOSED USING AN ENDOSTITCH DEVICE BY APPROXIMATING RIGHT CRURA T

  Patient problems: Abscess; Inflammation; Seroma; Swelling/ Edema

  MAUDE report 20342654 ↗
• InjuryOct 1, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE SAC WAS INCISED. A SMALL VENTRALEX ST MESH (DEVICE #1) WAS USED INTO THE EXTRAPERITONEAL SPACED AND SUTURED.¿ (B)(6) 2013 TO (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCOMPLETE PRIMARY HEALING AND FLUID ACCUMULATION. (B)(6) 2013 TO (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH WOUND INFECTION THEREBY UNDERWENT WOUND CARE. (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH NON-HEALING UMBILICAL WOUND AND INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF ABSORBABLE MESH AND EXPLANT OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE MESH PRODUCTS AND SUTURES WERE CAREFULLY DISSECTED AND REMOVED. THE RESULTING DEFECT WAS PALPATED. THERE WAS SO ADHERENT SMALL BOWEL. THIS WAS CLOSED WITH A DOUBLE LAYER OF ABSORBABLE MESH AND SUTURED.¿ (B)(6) 2013 - PATIENT UNDERWENT HIATAL HERNIA REPAIR THEREBY UNDERWENT PLACEMENT OF AP STANDARD LAP-BAND WITH E2 PORT. PER OPERATIVE NOTES, ¿THE HERNIA DEFECT WAS IDENTIFIED. THE DEFECT WAS CLOSED USING AN ENDOSTITCH DEVICE BY AP

  Patient problems: Abscess; Inflammation; Seroma; Swelling/ Edema

  MAUDE report 20342649 ↗
• MalfunctionJun 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED AFTER OPENING THE PACKAGE OF A BARD SOFT MESH ON 21-MAY-2024, A FOREIGN MATERIAL (HAIR) WAS STUCK TO THE MESH ITSELF. THE DEVICE WAS NOT USED ON THE PATIENT, THE PROCEDURE WAS COMPLETED BY USING A NEW DEVICE. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511407 ↗
• InjuryMay 10, 2024Defective Device; Patient-Device Incompatibility; 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 MARLEX MESH (BARD FLAT MESH), SEPRAMESH COMPOSITE IP AND BARD SOFT MESH ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH COMPOSITE IP. IT IS ALLEGED THAT THE PATIENT HAD REVISION SURGERY ON OR ABOUT (B)(6) 2018 WITH REMOVAL OF HERNIA MESH AND IMPLANT OF ADDITIONAL HERNIA MESH. IT ALSO ALLEGED THAT THE PATIENT UNDERWENT REVISION SURGERY ON OR ABOUT (B)(6) 2022 FOR ADDITIONAL HERNIA MESH. 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. NOTE: IT IS ALLEGED THAT THE PATIENT UNDERWENT EXPLANT OF HERNIA MESH AND REVISION SURGERY FOR ANOTHER MESH (DEVICE #1 #2).

  Patient problems: Hernia; Insufficient Information; Pain

  MAUDE report 19288044 ↗
• InjuryApr 30, 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 SOFT MESH. CASE-SPECIFIC DETAILS NOT PROVIDED. ADDENDUM PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD SOFT MESH ON (B)(6) 2016. PER OPERATIVE NOTES, ¿ADHESIOLYSIS WAS COMPLETED, AND THE SAC WAS EXCISED. A COUPLE OF SMALL DEFECTS WERE CLOSED WITH PROLENE SUTURES. A BARD SOFT MESH WAS TRIMMED TO OVAL AND WAS SECURED INTO THE FASCIA.¿ (B)(6)2016 - PATIENT WAS DIAGNOSED WITH WOUND INFECTION. (B)(6)2016 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN AND WOUND DEHISCENCE. (B)(6)2016 - PATIENT HAD ABSCESS AND DRAINING OF ANTERIOR ABDOMINAL WALL. THE CAVITY WAS WASHED. THE LIGHTWEIGHT MESH (BARD SOFT MESH) WAS IDENTIFIED AND LEFT IN PLACE. (B)(6) 2016 - PATIENT HAD WOUND CARE.

  Patient problems: Abscess; Bacterial Infection; Insufficient Information; Wound Dehiscence

  MAUDE report 19211688 ↗
• InjuryApr 30, 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 SOFT MESH. CASE-SPECIFIC DETAILS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19211600 ↗
• InjuryApr 26, 2024Defective Device; Patient-Device Incompatibility; 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 SOFT MESH AND BARD/DAVOL MARLEX (BARD FLAT MESH) ON (B)(6) 2017 AND/OR (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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; Pain

  MAUDE report 19190414 ↗
• InjuryApr 26, 2024Defective Device; Patient-Device Incompatibility; 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 SOFT MESH AND BARD/DAVOL MARLEX (BARD FLAT MESH) ON (B)(6) 2017 AND/OR (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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; Inflammation; Insufficient Information

  MAUDE report 19190412 ↗
• InjuryMar 7, 2024Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD SOFT MESH ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD SOFT 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: Hernia; Insufficient Information

  MAUDE report 18854529 ↗
• InjuryOct 19, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE ¿COMPARISON OF PERIOPERATIVE OUTCOMES BETWEEN NON-OBESE AND OBESE PATIENTS UNDERGOING ROBOTIC INGUINAL HERNIA REPAIR: A PROPENSITY SCORE MATCHING ANALYSIS.¿ THE ARTICLE DESCRIBES A RETROSPECTIVE STUDY WITH THE AIM OF TO COMPARE THE OUTCOMES OF ROBOTIC INGUINAL HERNIA REPAIR (RIHR) BETWEEN OBESE AND NON-OBESE PATIENTS AT A SINGLE CENTER. THE STUDY CONSISTED OF 547 PATIENTS, 414 WERE NON-OBESE AND 133 WERE OBESE, WHO UNDERWENT RIHR BETWEEN FEBRUARY 2013 TO AUGUST 2020. THE HERNIA REPAIRS FOR 29 OF THE 547 PATIENTS UTILIZED A BARD/BD 3DMAX MESH, AND 1 PATIENT WAS IMPLANTED WITH A BARD/BD SOFT MESH. THE REMAINING 517 PATIENTS WERE IMPLANTED WITH A NON-BARD/BD MESH AS PART OF THEIR HERNIA REPAIRS. THE ARTICLE DOES NOT REPORT ANY DEVICE SPECIFIC ISSUE RELATED TO THE HERNIA MESHES. THE OVERALL PATIENT OUTCOMES REPORTED INCLUDED SURGICAL SITE INFECTION (3), SEROMA (11), HEMATOMA (10) AND PROCEDURAL INTERVENTION (5). THE ARTICLE DOES NOT INDICATE THE MESH TYPE RELATED TO ANY OF THE REPORTED POSTOPERATIVE OUTCOMES, THEREFORE IT IS UNKNOWN WHICH, IF ANY, OF THE REPORTED OUTCOMES WERE ASSOCIATED WITH THE HERNIA REPAIRS THAT UTILIZED EITHER THE BARD/BD 3DMAX OR SOFT MESH DEV

  Patient problems: Insufficient Information

  MAUDE report 17964678 ↗
• InjuryMar 15, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL PHASIX ST (X2) ON (B)(6) 2019 AND BARD SOFT MESH ON (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE DEVICES. 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: Abscess; Adhesion(s); Insufficient Information; Necrosis

  MAUDE report 16544011 ↗