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); Pain (1994); Hernia (2240)
Date of Event	12/31/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2008 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per op notes, "an incision was made in the previous scar.The hernia sac was encountered and was dissected away from the surrounding tissue.A ventralex mesh (device 1) was placed into the peritoneal cavity using sutures.¿ (b)(6) 2008 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with explant of ventralex mesh (device 1) and implant of synthetic mesh.Per op notes, ¿an incision was made in the previous scar and extended down to the subcutaneous tissue.The ventralex mesh (device1) was well incorporated and densely adherent to the fascia.The previous ventralex mesh (device 1) was excised.Two synthetic meshes were placed at inner and outer layer and were secured with sutures.¿ (b)(6) 2009 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with explant of synthetic mesh and implant of bard flat mesh (device 2).Per op notes, ¿the synthetic meshes along with the tacks were removed.A bard flat mesh (device 2) was placed on the undersurface of the fascia using sutures.¿ (b)(6) 2018 - patient underwent lysis of adhesions.(b)(6) 2019 - patient underwent explant of bard flat mesh (device 2).(note: no op notes provided).
Event or Problem Description
Per information provided: on (b)(6) 2008- patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per op notes, "a longitudinal incision was made in the previous scar.The incision was extended through the subcutaneous tissue.The hernia sac was encountered and was dissected away from the surrounding tissue and was resected.A reducible small bowel was identified.A ventralex mesh (device 1) was placed into the peritoneal cavity in an inlay fashion, and the straps were pulled and sutured to the fascia margin using sutures." on (b)(6) 2008- patient was diagnosed with recurrent ventral hernia, adhesions, pain thereby underwent open repair with explant of ventralex mesh (device 1) and implant of synthetic mesh.Per op notes, "an incision was made in the previous scar and extended down to the subcutaneous tissue.No infection or seroma was found.The incision was further extended down to the previously placed ventralex mesh (device1).Very fine adhesions were found ptfe side of the previous mesh.The previous ventralex mesh (device 1) was excised.A ventral hernia repair was performed using a sandwich two-layer technique.Two synthetic meshes were placed at inner and outer layer and were secured with sutures." on (b)(6) 2009- patient was diagnosed with recurrent ventral hernia thereby underwent open repair with explant of synthetic mesh and implant of bard flat mesh (device 2).Per op notes, "the old midline scar was excised and dissection was carried down to the mesh in the midline.To the left of the previous mesh (ventralex mesh -device1) a ventral hernia was identified and dissected free, the hernia sac which contained small bowel was opened and the bowel adhesions to the inside of the peritoneum were divided.The omentum, small bowel adhesions to the undersurface of the fascia were taken down.The synthetic meshes along with the tacks were removed.The omentum was placed over the bowel.A bard flat mesh (device 2) was placed on the undersurface of the fascia and was secured with sutures." on (b)(6) 2019- patient underwent explant of bard flat mesh (device 2).
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.Addendum: h11: this supplemental mdr is submitted to correct the short description, event description, relevant test/laboratory data, other relevant history.Updated fields: b4, g3, g6, h2, h10, h11.Corrected fields: b5 (describe event or problem), b6 (relevant tests/laboratory data), b7 (other relevant history).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.
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 emdr represents the ventralex mesh (device 1).An additional supplemental emdr was submitted to represent the bard flat mesh (device 2).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.

• 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 ; +1(800)556-6756
• MDR Report Key: 50540247
• Report Number: 1213643-2026-01138
• Device Sequence Number: 9476142
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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 Catalogue Number: 0010303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 45 YR
• Patient Sex: Male