MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 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); Hernia (2240)
Date of Event	09/23/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with ventral hernia thereby underwent repair with the implant of sepramesh ip (device #1).(no operative notes were provided).(b)(6) 2013 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of ventralex mesh (device #2).Per operative notes, ¿the anterior wall was cleared of adhesions.The hernia sac was excised.Then a ventralex mesh (device #2) was placed flat and up against the abdominal wall using sutures and staples.¿ (note: there was no visualization/mention of sepramesh ip (device #1)).(b)(6) 2016 - patient was diagnosed with recurrent ventral hernia and adhesions thereby underwent repair with removal of sepramesh ip (device #1) and ventralex mesh (device #2) and implant of bard flat mesh (device #3).(no operative notes were provided).(b)(6) 2018 - patient was diagnosed with symptomatic ventral hernia with incarceration and bowel obstruction thereby underwent open repair with implant of polypropylene mesh.Per operative notes, ¿hernia defect identified at the umbilicus and loop of bowel remaining incarcerated.Bowel loop was dissected free from peritoneum.Serosal tears were closed.A polypropylene patch was fashioned to size and placed over the defect and secured with sutures.¿ (there was no visualization/mention of bard flat mesh (device #3)).Attorney alleged that the patient had adhesions, bowel/intestinal obstruction, hernia recurrence, mesh migration, mesh shrinkage, pain & suffering.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 3 years 4 months post implant of ventralex mesh, patient was diagnosed with hernia recurrence and adhesions thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.This emdr represents mesh ¿ ventralex (device #2).An additional supplemental emdr was submitted to represent sepramesh ip (device #1) and an additional emdr was submitted to represent bard flat mesh (device #3).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.

• Brand Name: MESH ¿ VENTRALEX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 20863199
• Report Number: 1213643-2024-094842
• Device Sequence Number: 15679792
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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: 11/12/2024
• Initial Report FDA Received Date: 12/06/2024
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 121 KG