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

Catalog Number	5950007
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	02/03/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012: patient was diagnosed with 2 ventral hernias thereby underwent open repair with implant of ventralex st (device 1).Per op notes, ¿previous incision was reopened in umbilicus.The hernia sac was opened and adhesions were taken down.The defect was repaired with sutures.Another hernia defect was noted on left lower quadrant.The sac was opened and adhesions were lysed.A ventralex st (device 1) was placed on llq and sutured.¿ (b)(6) 2013: patient was diagnosed with recurrent two ventral hernias thereby underwent open repair with implant of ventralex st (device 2 and 3).Per op notes, ¿the hernia sac was identified and freed back at the level of fascia.Excess sac was excised.Adhesions of both prior incision sites were lysed.Both defects were noted.Two ventralex st (device 2 and 3) near umbilicus and llq were placed on both defects intraperitoneally and sutured.¿ (b)(6) 2014: patient was diagnosed with recurrent multiple ventral incisional hernias thereby underwent laparoscopic repair with excision of ventralex st (device 1,2 and 3) and implant of synthetic mesh.Per op notes, ¿significant adhesions were noted in abdominal wall was lysed.Swiss cheese recurrent hernias with incarcerated omentum were noted and reduced.Multiple loops of small bowel were released.The bowel was ingrown into old mesh (device 1,2 and 3).The mesh near the umbilicus (device 2) was transected.Old llq defect was noted and reduced.Another meshes (device 1 and 3) were transected.Multiple defects were reduced.A large synthetic mesh was placed and secured using 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.Note, the manufacturing date (15-may-2013) is considered to be a best estimate.This mdr represents the ventralex st (device 3).Additional supplemental emdr¿s were submitted to represent the ventralex st (device 1) and ventralex st (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: 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: 24483442
• Report Number: 1213643-2026-00262
• Device Sequence Number: 4966945
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472(17)150528(10)HUXE1303
• 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: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 05/28/2015
• Device Catalogue Number: 5950007
• Device Lot Number: HUXE1303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2013
• 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: 54 YR
• Patient Sex: Male