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

Catalog Number	5950009
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	08/08/2016
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.Note, the manufacturing date (15-jun-2015) is considered to be a best estimate.This emdr represents the ventralex st mesh (device 2).An additional supplemental emdr was submitted to represent the ventralex 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.
Event or Problem Description
Per information provided: on (b)(6) 2012 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventralex st mesh (device 1).Per operative notes, ¿an incision was made into the abdomen.The hernia sac was dissected out.A ventralex st mesh (device 1) was placed into the defect and closed with sutures.¿ on (b)(6) 2013 - patient was diagnosed with recurrent incisional hernia, pain thereby underwent open repair with explant of ventralex st mesh (device 1) and implant of synthetic mesh.Per operative notes, ¿a previous lower midline incision was reopened.The hernia sac was dissected out.Previously placed ventralex st mesh (device 1) was removed entirely.A synthetic mesh was placed into the defect and sutured.¿ on (b)(6) 2015 - patient was diagnosed with recurrent incisional hernias and umbilical hernias, adhesion, thereby underwent open repair with implant of ventralex st mesh (device 2 and device 3).Per operative notes, ¿a lower skin incision was made through previous surgical scar.The hernia sac was noted, which was excised.There was dense number of adhesions, which were taken down.A ventralex st mesh (device 2) was placed into the peritoneum space and sutured.A small incision was made into the umbilicus.The umbilical hernia sac was dissected out.A ventralex st mesh (device 3) was placed into the umbilical region and secure it with sutures.¿ on (b)(6) 2016 - patient was diagnosed with recurrent incisional hernia, adhesion thereby underwent open repair with implant of ventralex st mesh (device 4).Per operative notes, ¿a small skin incision was made just below the umbilicus through previous lower midline surgical scar.There was incisional hernia just below the umbilicus.Previous mesh was identified just superior to the defect.All adhesions were taken down.A ventralex st mesh (device 4) was placed into the defect and closed with sutures.¿.

• 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: 24256491
• Report Number: 1213643-2026-00079
• Device Sequence Number: 20921693
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)170628(10)HUZF0083
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 06/28/2017
• Device Catalogue Number: 5950009
• Device Lot Number: HUZF0083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2015
• 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: 63 YR
• Patient Sex: Female