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

Catalog Number	0010303
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Inflammation (1932); Hernia (2240)
Date of Event	01/16/2018
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.Note, the manufacturing date (15-jun-2012) is considered to be a best estimate.This emdr represents the ventralex mesh (device 2).Additional supplemental emdrs were submitted to represent the ventralex mesh (device 1) and ventrio mesh (device 3).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) 2013 - patient was diagnosed with ventral hernia x 2 thereby underwent open repair with implant of ventralex mesh (device 1 and 2).Per op notes, "an incision was made over the large defect.The hernia sac was dissected away and amputated.A single defect was identified above the umbilicus and it was reduced.An incision was made over this.The hernia sac was amputated at the fascial level.Defect in the lower portion was identified and an ventralex mesh (device 1) was placed into the abdomen and secured with sutures.The upper defect was repaired in a similar fashion with ventralex mesh (device 2) and the wound was closed with suture." on (b)(6) 2014 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventrio mesh (device 3).Per op notes, "the previous lower midline incision was opened from the umbilicus.Hernia sac was identified and dissected down to the fascia and removed.Intra-abdominal contents dissected away from the fascial defect.The edges of the fascial defect were approximated with suture.This left a small defect.A ventrio mesh (device 3) was placed in the defect and tacked anteriorly to the abdominal wall.Fascia was then reapproximated with suture." on (b)(6) 2018 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with excision of ventralex mesh (device 1 and 2) and ventrio mesh (device 3) and implant of synthetic mesh.Per op notes, "a transverse incision was made over the hernia defect infraumbilical.The hernia sac was identified and dissected.Superior most hernia was identified periumbilically.A cheese-like material overlying the hernia was noted and extended down to the prior mesh on the lower abdominal wall and this was dissected.An incarcerated hernia in the upper abdomen was identified and reduced.Adhesions between omentum and the anterior abdominal wall were noted and between the small bowel and prior mesh were noted.These were taken down.The small bowel was densely adherent to the undersurface of two pieces of mesh (device 1 and 3) that were intertwined.The lower mesh (device 3) was removed first and excised the two pieces (device 1 and 3) of mesh with the overlying cavity.A second piece (device 2) of mesh was removed as well.There were omental adhesions to this and lysed.A synthetic mesh was placed and secured with suture.".

• Brand Name: MESH - VENTRALEX
• 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: 25704358
• Report Number: 1213643-2026-00849
• Device Sequence Number: 18559361
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486(17)170628(10)HUWF0880
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: 06/28/2017
• Device Catalogue Number: 0010303
• Device Lot Number: HUWF0880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2012
• 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: 50 YR
• Patient Sex: Female