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

Catalog Number	0010303
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)
Date of Event	11/29/2010
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.This emdr represents the ventralex mesh (device #2).An additional supplemental emdr was submitted to represent the composix e/x 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) 2003: patient was diagnosed with incarcerated ventral hernia thereby underwent laparoscopic repair with the implant of composix e/x mesh (device #1).Per operative notes, ¿there was a quite a bit of omentum incarcerated within the symptomatic ventral hernia.Adhesion from the omentum was excised and all previous incision were taken down carefully.A composix e/x mesh was placed and secure it with suture.¿ on (b)(6) 2008: patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of two synthetic mesh and one large ventralex mesh (device #2).Per operative notes, ¿there was multiple omentum adhesion was there.There was a recurrent hernia in the lower abdomen with what appeared to be composix e/x (device #1) mesh as the hernia sac.Adhesions were removed.Two synthetic mesh was then placed and tacked with suture.Left upper quadrant a large ventralex mesh (device #2) was then placed and sutured.¿ on (b)(6) 2008: patient was diagnosed with infected intraabdominal clot thereby underwent laparoscopic repair with explant of composix e/x mesh (device #1) and synthetic mesh.Per operative notes, ¿the blood clot was evacuated.Sepsis happened because of the mesh.The composix e/x mesh (device #1) and synthetic mesh was removed.¿ on (b)(6) 2010: patient was diagnosed with recurrent incisional hernia, small bowel adhesion thereby underwent laparoscopic repair with implant of two synthetic mesh.Per operative notes, ¿small bowel adhesion was taken down.Two synthetic mesh was then placed and secure it with suture.¿ attorney alleges that the patient had adhesions, hernia recurrence, infection and emotional injuries.

• 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 ; 4018258495
• MDR Report Key: 21958438
• Report Number: 1213643-2025-090195
• Device Sequence Number: 7265149
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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 Catalogue Number: 0010303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 44 YR
• Patient Sex: Female