MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Ventralight ST Mesh; Surgical Mesh

Catalog Number	5954680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Necrosis (1971); Post Operative Wound Infection (2446)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2015 - patient was diagnosed with large ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh using echo ps (device 1).Per op notes, "the hernia was reduced from the sac.A ventralight st mesh using echo ps (device 1) was placed into peritoneal cavity and overlapped the defect and secured to fascia using sorbafix tacks." on (b)(6)2016 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair.Per op notes, "the mesh (device 1) was tethered and stuck to the left lobe of the liver was left attached.Lysis of adhesions was done along the central abdomen down to the level of the recurrent ventral hernia.The stomach was found to be adhesed to the hernia contents and the anterior abdominal wall in the lower midline and sleeve was resected." on (b)(6) 2019 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventralight st mesh (device 2).Per op notes, "the hernia was noted just to the right of midline.A ventralight st mesh (device 2) was placed in retrorectus space and sutured the mesh edges to the anterior abdominal wall fascia using sutures." on (b)(6) 2019 - patient was diagnosed with wound infection thereby underwent debridement and incision of subcutaneous tissue of abdominal wound.Per op notes, "the previous transverse supraumbilical incision was irrigated.Necrotic tissue was excised." (note: there was no discrete abscess or foreign body to account for the infection).On (b)(6) 2019 - patient was diagnosed with abdominal wound infection thereby underwent washout of abdominal wound.Per op notes, "there was good granulation tissue on the base of the wound.Some fat necrosis was excised." (note : there is no mention/ visualization of previous meshes in this procedure).
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-jan-2018) is considered to be a best estimate.This emdr represents the ventralight st mesh (device 2).An additional supplemental emdr was submitted to represent the ventralight st mesh (device 1).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: Ventralight ST Mesh
• 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: 50140030
• Report Number: 1213643-2026-01006
• Device Sequence Number: 10731298
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656(17)200228(10)HUCN1891
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 02/28/2020
• Device Catalogue Number: 5954680
• Device Lot Number: HUCN1891
• 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: 07/22/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2018
• 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 Sex: Female