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	Necrosis (1971); Sepsis (2067); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)
Date of Event	04/09/2012
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 emdr represents the bd mesh - ventralex mesh (device 1).An additional supplemental emdr was submitted to represent the bd mesh - ventralex 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.
Event or Problem Description
Per information provided: on (b)(6) 2008: patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per operative notes, ¿a sizeable incisional hernia in the upper midline was reduced and large piece of ventralex mesh (device 1) was placed and anchored it circumferentially with sutures.¿ on (b)(6) 2011: patient was diagnosed with recurrent umbilical incisional hernia thereby underwent open repair with implant of ventralex mesh (device 2).Per operative notes, ¿an umbilical incisional hernia in the infraumbilical area was dissected and small piece of ventralex mesh (device 2) was placed and anchored circumferentially.¿ on (b)(6) 2012: patient was diagnosed with postoperative wound infection with sepsis thereby underwent open repair.Per operative notes, ¿the prior old meshes (device 1 and 2) were intact.A well incapsulated chronic seroma was drained and necrotic tissue were closed with sutures.¿ on (b)(6) 2012: patient was diagnosed with recurrent incisional hernia, chronic seroma with chronic abdominal pain thereby underwent open repair with removal of old meshes and implant of xenmatrix mesh (device 3).Per operative notes, ¿the old meshes (device 1 and 2) with fair amount of fibrotic, inflamed and scarred tissues were removed.The seroma cavity on both sides of the midline was drained.The fascia was closed with sutures and xenmatrix mesh (device 3) was placed and sutured.¿ on (b)(6) 2012: patient was diagnosed with abdominal wound abscess with infected infusion port thereby underwent open repair.Per operative notes, ¿the infusion port placed for the previous laparoscopic banding surgery was infected and completely removed.The abscess was drained, and wound was irrigated with sutures.¿ (note: the previously placed mesh (device 3) was not seen during this procedure.¿ on (b)(6) 2017: patient was diagnosed with suture granuloma of abdominal wall thereby underwent excision of granuloma.Per operative notes, ¿granuloma from the previous prolene sutures were removed.The fascia was closed secured with sutures.¿.
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 emdr is submitted to correct the date of implant.Updated fields: b2, b4, d1, g3, g6, h2, h6, h10, h11 corrected field: d.6a (date of implant) this supplemental emdr represents the bd mesh - ventralex mesh (device 1).An additional supplemental emdr was submitted to represent the bd mesh - ventralex 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.
Event or Problem Description
Per information provided: on (b)(6) 2008 ¿ patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per operative notes, ¿a sizeable incisional hernia in the upper midline was reduced and large piece of ventralex mesh (device 1) was placed and anchored it circumferentially with sutures.¿ on (b)(6) 2011 ¿ patient was diagnosed with recurrent umbilical incisional hernia thereby underwent open repair with implant of ventralex mesh (device 2).Per operative notes, ¿a umbilical incisional hernia in the infraumbilical area was dissected and small piece of ventralex mesh (device 2) was placed and anchored circumferentially.¿ on (b)(6) 2012 ¿ patient was diagnosed with postoperative wound infection with sepsis thereby underwent open repair.Per operative notes, ¿the prior old meshes (device 1 and 2) were intact.A well incapsulated chronic seroma was drained and necrotic tissue were closed with sutures.¿ on (b)(6) 2012 - patient was diagnosed with recurrent incisional hernia, chronic seroma with chronic abdominal pain thereby underwent open repair with removal of old meshes and implant of xenmatrix mesh (device 3).Per operative notes, ¿the old meshes (device 1 and 2) with fair amount of fibrotic, inflamed and scarred tissues were removed.The seroma cavity on both sides of the midline was drained.The fascia was closed with sutures and xenmatrix mesh (device 3) was placed and sutured.¿ on (b)(6) 2012 - patient was diagnosed with abdominal wound abscess with infected infusion port thereby underwent open repair.Per operative notes, ¿the infusion port placed for the previous laparoscopic banding surgery was infected and completely removed.The abscess was drained, and wound was irrigated with sutures.¿ (note: the previously placed mesh (device 3) was not seen during this procedure.¿ on (b)(6) 2017 - patient was diagnosed with suture granuloma of abdominal wall thereby underwent excision of granuloma.Per operative notes, ¿granuloma from the previous prolene sutures were removed.The fascia was closed secured with sutures.¿.

• 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: 23448778
• Report Number: 1213643-2025-01058
• Device Sequence Number: 9174380
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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: Disability; Life Threatening; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 111 KG