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); Obstruction/Occlusion (2422)
Date of Event	08/31/2017
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-mar-2016) is considered to be a best estimate.This mdr represents the ventralex st mesh (device 3).An additional supplemental emdr was submitted to represent the ventralight st using echo ps (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) 2016- patient was diagnosed with ventral hernia, left inguinal hernia, thereby underwent laparoscopic repair with implant of ventralight st using echo ps (device 1), 3dmax mesh (device 2).Per op notes, ¿a ventral hernia in abdominal region was identified and dissected.A ventralight st using echo ps (device 1) was placed intra-abdominally was placed in double crown technique.The hernia sac in left inguinal region was repaired by placing a 3dmax mesh (device 2) and sutured¿.(b)(6) 2016- patient was diagnosed with recurrent ventral hernia, thereby underwent laparoscopic repair with implant of ventralex st mesh (device 3).Per op notes, ¿omentum in the left upper quadrant was reduced.There was no evidence of adhesion or obstruction.A small ventralex st mesh was placed and tacked¿.(b)(6) 2017- patient was diagnosed with small bowel obstruction, adhesion, thereby underwent open repair with partial explant of ventralight st using echo ps (device 1), ventralex st mesh (device 3).Per op notes, ¿the adhesions in the abdominal region was taken down along with the portion of mesh (device 1 and 3)¿.

• 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: 24469190
• Report Number: 1213643-2026-00250
• Device Sequence Number: 16017908
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472(17)180428(10)HUAQ2143
• 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: 2016
• Device Explanted Year: 2017
• 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: 04/28/2018
• Device Catalogue Number: 5950007
• Device Lot Number: HUAQ2143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2016
• 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: 79 YR
• Patient Sex: Male