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

Catalog Number	0010212
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Insufficient Information (4580)
Date of Event	04/16/2019
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 st (device #2).An additional emdr was submitted to represent the bard/davol mesh ¿ composix kugel (device #1) and the bard/davol mesh ¿ composix kugel (device #3).Should additional information be provided, a supplemental emdr will be submitted.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
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix kugel hernia patch and ventrio st on (b)(6)2011 and/or (b)(6)2015 and/or (b)(6)2019.As reported, the patient is making a claim for an adverse patient outcome against all the devices.It is alleged that the patient sustained injuries on (b)(6)2014, (b)(6)2015 and (b)(6)2019.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 composix kugel hernia patch and ventrio st on (b)(6) 2011 and/or (b)(6) 2015 and/or (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against all the devices.It is alleged that the patient sustained injuries on (b)(6) 2014, (b)(6) 2015 and (b)(6) 2019.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) 2011 - patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of composix kugel mesh (device 1).Per op notes, "a composix kugel mesh (device 1) was placed into the abdomen using tacks." (b)(6) 2014 - patient was diagnosed with incisional hernia thereby underwent repair with partial removal of mesh (device 1).Per op notes, "the small bowel was densely adherent to the mesh and the mesh was separated from the abdomen.The mesh (device 1) was dissected." (b)(6) 2015 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventrio (device 2).Per op notes, "the old mesh (device 1) was noted.A ventrio (device 2) was placed intra abdominally using sutures." (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia thereby underwent repair with the removal of mesh (device 1 and 2) and implant of ventrio st (device 3).Per op notes, "there were two pieces of mesh which were densely adherent to the bowel.Extensive lysis of adhesions was performed.A ventrio st (device 3) was placed into the abdomen using sutures.".
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: h11: this supplemental emdr is submitted to document additional information provided and to correct the product identifiers.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-jun-2014) is considered to be a best estimate.This supplemental emdr represents the bd ventrio mesh (device 2).An additional supplemental emdr was submitted to represent the bd mesh ¿ composix kugel (device 1) and the bd ventrio st (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: VENTRIO MESH
• 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: 16951263
• Report Number: 1213643-2023-092031
• Device Sequence Number: 3300929
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394(17)170628(10)HUYF1047
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 06/28/2017
• Device Catalogue Number: 0010212
• Device Lot Number: HUYF1047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2014
• 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: Disability; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female