MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO ST; SURGICAL MESH

Catalog Number	5950030
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This mdr represents the ventrio st mesh (device 4).An additional supplemental emdr was submitted to represent the dulex mesh (device 1), composix l/p mesh (device 2) and ventralex st mesh (device 3).Note, the manufacturing date (15-jan-2017) is considered to be a best estimate.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
Per information provided: on (b)(6) 2010 ¿ patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with implant of dulex mesh (device 1).Per op notes, ¿epigastric incision in the midline was made.The hernia defect was noted.A dulex mesh (device 1) was placed and secured with sutures and absorbable tacker.(b)(6) 2011 ¿ patient was diagnosed with subxiphoid port site incisional hernia thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes, ¿adhesions to the previous mesh repair to the periumbilical area was taken down.The hernia defect was identified and approximated with sutures.A synthetic mesh was placed into the peritoneal cavity and secured with sutures and tacks.¿ (b)(6) 2012 ¿ patient was diagnosed with recurrent incisional port site hernia, recurrent subxiphoid right mid quadrant thereby underwent laparoscopic repair with implant of composix l/p mesh (device 2) for subxiphoid defect and synthetic mesh for right mid quadrant defect.Per op notes, ¿adhesions in the subxiphoid area were taken down and free up the loop of bowel and edge of the liver, which was attached to the edge of the mesh, which was at the superior edge of the double barrel defect in the fascia.A composix l/p mesh (device 2) was placed in the peritoneal cavity and secured with sutures and tacks.A right mid quadrant fascial defect was noted and a synthetic mesh was placed into the peritoneal cavity and secured with sutures and tacks.¿ (b)(6) 2014 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of ventralex st mesh (device 3).Per op notes, ¿the previous incision was reopened above the umbilicus.The hernia sac was identified.Upon dissection, second hernia sac was identified.Adhesions to the fatty tissue to the sac were taken down.One small hernia to the right of the main area was identified and sutured.Two other defects were connected to the main defect to make one larger defect.The small right sided defect was repaired with sutures.The larger defect was repaired with ventralex st mesh (device 3) and secured with sutures.¿ (b)(6) 2017 - patient was diagnosed with incisional hernia thereby underwent laparoscopy converted to open repair.Per op notes, ¿a midline incision was made.The fascia was taken down and multiple pieces of mesh that had to be transected.Colotomy was identified and repaired with sutures.Abscess in the lower pelvis was noted.There was an area adherent to the vaginal cuff was taken off.The colon created a stricture in the shape of z and transected and taken down.The proximal sigmoid colon was then opened and placed sizers in it.Rectal exam was performed and placed the sizers.An area in the right lower quadrant was then excised.The fascia/mesh was closed with sutures.¿ (b)(6) 2017 ¿ patient was diagnosed with diverticulitis thereby underwent open repair.Per op notes, ¿an elliptical incision was made.The limb was noted to be partially adherent to the previously placed mesh which was loosened and lengthened to do the resection.Enterotomies were made and anastomosis was created.The parastomal hernia component was lysed and reduced.The fascia was closed with sutures.¿ (b)(6) -2018 ¿ patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with implant of ventrio st mesh (device 4).Per op notes, ¿an incision was made through previous incision.The supraumbilical hernia sac with 2 defects were identified.Dissected the bowel off the left lateral sac and reduced.The hernia sac was dissected down to the neck and resected.Intraabdominal adhesions were lysed.Small ooze in the bowel wall was repaired with sutures.Small serosal tear was repaired with sutures.A piece of mesh superiorly with spiral tacks within it and a piece of mesh inferiorly with sutures were noted to be well incorporated.A ventrio st mesh (device 4) was placed and secured with sutures.¿ (b)(6) 2019 ¿ patient was diagnosed with recurrent incisional ventral hernia thereby underwent open repair with implant of ventrio st mesh (device 5).Per op notes, ¿an incision was made in the midline just below the umbilicus.The hernia sac was noted to be chronically incarcerated and tunneled into the subcutaneous tissues.Scar tissue was noted.Hernia sac and omentum to be adherent to the side wall which was taken down and reduced.A ventrio st mesh (device 5) was placed and secured with sutures.¿.

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 24590391
• Report Number: 1213643-2026-00332
• Device Sequence Number: 9331448
• Product Code: FTL
• UDI-Device Identifier: 00801741031526
• UDI-Public: (01)00801741031526(17)190228(10)HUBN1763
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 5950030
• Device Lot Number: HUBN1763
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 116 KG