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

Catalog Number	5950008
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erythema (1840); Fistula (1862); Unspecified Infection (1930)
Date of Event	10/26/2018
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.This mdr represents the ventralex st mesh (device 3).An additional mdr was submitted to represent the ventralex mesh (device 2).An additional supplemental emdr was submitted to represent the composix l/p 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.
Event or Problem Description
Per information provided: (b)(6) 2006: patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with implant of composix l/p mesh (device 1).Per op notes, ¿the midline hernia was identified and the omental adhesions going up into the hernia were reduced.There was one portion of old mesh in the right lower quadrant and left undissected.A symptomatic portion of open hernia in upper midline region was identified.A composix l/p mesh (device 1) was placed in the abdominal cavity and tacked¿.(note: the old mesh seen during this procedure was unknown) (b)(6) 2013: patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with implant of ventralex mesh (device 2).Per op notes, ¿hernia sac was identified in the abdominal region and was dissected.A ventralex mesh (device 2) was placed in the preperitoneal space and sutured¿.(b)(6) 2015: patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with implant of ventralex st mesh (device 3).Per op notes, ¿hernia sac was identified in the abdominal cavity.There were adhesions noted with the edges of hernia and was lysed.A ventralex st mesh (device 3) was placed in the preperitoneal space and sutured¿.(b)(6) 2018: patient was diagnosed with erythema, thereby underwent open repair with explant of infected mesh (composix l/p mesh- device 1, ventralex mesh-device 2, ventralex st mesh- device 3).Per op notes, ¿area of small bowel adherent to the mesh forming a fistula which was excised.Adhesions were noted to the underside of mesh.The infected mesh (composix l/p mesh- device 1, ventralex mesh-device 2, ventralex st mesh- device 3) were excised from the abdominal wall.¿.

• Brand Name: VENTRALEX 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: 24267136
• Report Number: 1213643-2026-00090
• Device Sequence Number: 18819989
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 01/21/2026

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: 5950008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/05/2026
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 96 KG