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

Catalog Number	0010212
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Insufficient Information (4580)
Date of Event	08/06/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol ventrio mesh (device #2).An additional emdr was submitted to represent the bard flat mesh (device #1).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol marlex mesh and ventrio on (b)(6) 2013 and/or (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol marlex mesh and ventrio on (b)(6) 2013 and/or (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with the implant of ventrio mesh (device #1).Per operative notes, ¿patient had a large ventral hernia.Adhesions from the small bowel within the hernia into the anterior abdominal wall, which were carefully lysed.A ventrio hernia patch (device #1) was used to reconstruct the abdominal wall using sutures.¿ on (b)(6) 2013, patient was diagnosed with infected ventral hernia mesh thereby underwent removal of mesh (device #1) and small bowel resection.Per operative notes, ¿patient¿s previous midline scar was excised.The mesh, there appeared to be several loops of bowel that were densely adherent to the mesh.Dissection was completed on both sides of the infected mesh (device #1).Appeared to be small fistulous tracts with the mesh.There was a small amount of pus coming from the phlegmonous mass.The small bowel was resected.¿ on (b)(6) 2014, patient was diagnosed with incarcerated right inguinal hernia thereby underwent open repair with the implant of bard flat mesh (device #2).Per operative notes, ¿the patient had 2 large defects in the posterior wall and the hernia sac was opened and the appendix and colon were reduced to the abdominal cavity.A bard flat mesh (device #2) was secured to the inguinal ligament using prolene sutures." on (b)(6) 2015, patient was diagnosed with epididymal cyst & testicular mass thereby underwent right inguinal exploration and excision of epididymal cyst.Per operative notes, ¿there was dense scar tissue.Expose the right cord structures to isolate them from the mesh.¿ attorney alleges that the abscess, infection, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information provided, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 6 months post implant of ventrio mesh, patient was diagnosed with infection, fistula, adhesions, abscess and scar tissue thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list infection, fistula, adhesions as possible complications.The warnings section of the ifu states, ¿if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require the removal of the device.¿.Review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-aug-2012) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventrio mesh (device #1).An additional supplemental emdr was submitted to represent the bard flat mesh (device #2).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: VENTRIO MESH
• 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: 12105299
• Report Number: 1213643-2021-05478
• Device Sequence Number: 4508650
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394(17)150828(10)HUWH0417
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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 Expiration Date: 08/28/2015
• Device Catalogue Number: 0010212
• Device Lot Number: HUWH0417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2012
• 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; Disability
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 131 KG