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

Catalog Number	0010302
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	01/24/2018
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.Note, the manufacturing date (15-apr-2012) is considered to be a best estimate.This emdr represents the ventralex mesh (device 2).An additional supplemental emdr was submitted to represent the ventralex 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 midline ventral hernia x2 thereby underwent open repair with implant of ventralex mesh (device 1 and 2).Per op notes, "two hernias were large but in close approximately in the midline.Midline scar was excised and dissected.Both hernias were identified and dissected free from the surrounding tissues.The hernias were dissected from fascia and both hernias were reduced.Two ventralex mesh (device 1 and 2) were placed for both hernias individually and sutured." on (b)(6) 2018 - patient was diagnosed with recurrent incarcerated incisional ventral hernia and umbilical hernia thereby underwent open repair with excision of ventralex mesh (device 1 and 2) and implant of synthetic mesh.Per op notes, "multiple omental adhesions to the incisional hernias were lysed.There was a more inferior ventral hernia fixed with prior intra-abdominal mesh (device 1) that had recurred.The hernia contents were reduced.There was a second epigastric hernia recurrence also with dense adhesions to the epigastric mesh (device 2) was noted and it contained omentum was reduced.Both meshes (device 1 and 2) were curled up on edges.The ventral mesh (device 1) was excised and removed.Then a second piece of mesh (device 2) was encountered and omental adhesions were lysed.The second mesh (device 2) was explanted and removed.A large synthetic mesh was placed to cover both defects and sutured.".

• Brand Name: MESH - VENTRALEX
• 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: 25680975
• Report Number: 1213643-2026-00844
• Device Sequence Number: 9595141
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)170628(10)HUWD0729
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K021736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 06/29/2026

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: 0010302
• Device Lot Number: HUWD0729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2012
• 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: 60 YR
• Patient Sex: Male