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

Catalog Number	0010303
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862); Unspecified Infection (1930)
Date of Event	06/20/2017
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-nov-2010) is considered to be a best estimate.This mdr 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: (b)(6) 2011 ¿ patient was diagnosed with ventral incisional hernia thereby underwent open repair with implant of two ventralex meshes (device 1 and 2).Per operative notes, ¿in the midline, the hernia sac was noted, and extensive intra-abdominal adhesions were reduced.The multiseptated hernia with smaller and larger defect in fascia just above the umbilicus was noted.The septation was left intact and smaller hernia was repaired with small circle ventralex mesh (device 1) and to the large hernia another large circle ventralex mesh (device 2) was placed and secured with sutures.¿ (b)(6) 2017 - patient was diagnosed with infected abdominal soft tissue wound with abscess thereby underwent open repair with abdominal wall washout and wound vac placement.Per operative notes, ¿the supraumbilical midline wound was irrigated.In the upper aspect of the wound, the infected meshes (device 1 and 2) were as exposed, wound was irrigated and wound vac was placed.¿ (b)(6) 2017 - patient was diagnosed with infected abdominal wall mesh (device 1 and 2) and enterocutaneous fistula thereby underwent open repair with removal of infected meshes (device 1 and 2).Per operative notes, ¿fistulous tract extending down to intra-abdominal mesh and dense abdominal adhesions were noted.The fistula, adhesions to anterior abdominal wall and interloop adhesions were taken down.The meshes (device 1 and 2) were removed.A segment of small bowel adhered to anterior abdominal wall was resected and sutured.¿ (b)(6) 2017 ¿ patient had anterior abdominal wall wound thereby underwent washout of anterior abdominal wall wound with delayed layer and primary closure.".

• 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: 24543411
• Report Number: 1213643-2026-00296
• Device Sequence Number: 9271961
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486(10)HUUK0212
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 03/04/2026

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: 11/28/2015
• Device Catalogue Number: 0010303
• Device Lot Number: HUUK0212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2010
• 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: 69 YR
• Patient Sex: Female