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

Catalog Number	0010211
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	10/10/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, post implant of ventrio mesh, patient was diagnosed with hernia recurrence, dehiscence and bowel obstruction thereby underwent removal of mesh.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.This emdr represents the ventrio mesh (device #2).An additional supplemental emdr was submitted to represent the mesh - ventralex (device #1) and an additional emdr was submitted to represent mesh - ventralex (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.H3 other text: not returned.
Event or Problem Description
Addendum per additional information provided: on (b)(6) 2012 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventralex mesh (device #1).Per operative notes, ¿the hernia sac was identified and excess sac was removed.Then a ventralex mesh was placed and sewn in place using sutures.¿ on (b)(6) 2013 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventrio mesh (device #2).Per operative notes, ¿the hernia sac was cleaned off and the old ventralex mesh (device #1) was part of the hernia sac.The excess sac was removed and a ventrio mesh was sewn in place using sutures.¿ on (b)(6) 2013 - patient was diagnosed with recurrent incisional hernia, bowel obstruction and dehiscence thereby underwent open repair with the implant of ventralex mesh (device #3) and removal of ventralex mesh (device #1) and ventrio mesh (device #2).Per operative notes, ¿the old ventralex mesh and ventrio mesh were removed and a new ventralex mesh was sewn in place using sutures.¿ on (b)(6) 2013 - patient was diagnosed with enterocutaneous fistula with abdominal wall cellulitis, abdominal pain and drainage has started to seep out of incision thereby underwent open repair with removal of infected ventralex mesh (device #3).Per operative notes, ¿there was succus and bilious wound drainage and the ventralex mesh was removed.Inflammation was noted and the rest of the wound was mostly just granulation tissue.Attorney alleges that the patient had pain, hernia recurrence and emotional injuries.

• 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: 20254894
• Report Number: 1213643-2024-094695
• Device Sequence Number: 12765778
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387(17)160428(10)HUXD0600
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/19/2024

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 Expiration Date: 04/28/2016
• Device Catalogue Number: 0010211
• Device Lot Number: HUXD0600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/19/2024
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 73 KG