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

Catalog Number	0010213
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Pain (1994); Hernia (2240); Injury (2348); Disability (2371); Impaired Healing (2378)
Date of Event	07/27/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventrio (device #3) used to treat the patient.No lot number has been provided therefore a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol ventrio (device #3).An additional emdr was submitted to represent the bard/davol ventralex (device #1) and bard/davol composix kugel (device #2).Note: not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2006: the patient underwent surgery for implant of an unspecified bard/davol ventralex (device #1).On (b)(6) 2006: the patient underwent surgery for implant of an unspecified bard/davol composix kugel (device #2).On (b)(6) 2012: the patient underwent surgery for implant of an unspecified bard/davol ventrio (device #3).The patient is making a claim for an adverse patient outcome against the ventralex (device #1), composix kugel (device #2), and ventrio (device #3).The patient's 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.".
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventrio (device #3) used to treat the patient.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.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-jul-2011) is considered to be a best estimate.This supplemental emdr represents the bard/davol - ventrio mesh (device 3).Additional supplemental emdr's were submitted to represent the ventralex mesh (device 1), composix kugel (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.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2006: the patient underwent surgery for implant of an unspecified bard/davol ventralex (device #1).(b)(6) 2006: the patient underwent surgery for implant of an unspecified bard/davol composix kugel (device #2).(b)(6) 2012: the patient underwent surgery for implant of an unspecified bard/davol ventrio (device #3).The patient is making a claim for an adverse patient outcome against the ventralex (device #1), composix kugel (device #2), and ventrio (device #3).The patient's 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." addendum per additional information provided: (b)(6) 2006 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per op notes, ¿the protruding peritoneum was noted and excised.A ventralex mesh (device 1) was placed and sutured.¿ (b)(6) 2006 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of composix kugel (device 2).Per op notes, ¿the adhesions of prior mesh (device 1) to abdominal wall were lysed, three hernia defects were noted in midline and reduced.A composix kugel (device 2) was placed and tacked using sutures.¿ (b)(6) 2012 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with implant of ventrio mesh (device 3).Per op notes, ¿prior midline incision was reopened.Encountered the peritoneal protrusion and recurrent hernia defect were noted just superior to prior meshes (device 1 and 2).Adhesions were lysed.Another hernia was noted and reduced.A ventrio mesh (device 3) was placed and tacked using sutures.¿ (b)(6) 2015 - patient was diagnosed with infected mesh, non-healing wound, enterocutaneous fistula and recurrent ventral hernia thereby underwent open repair with partial excision of ventralex (device 1), composix kugel (device 2), ventrio (device 3) and implant of xenmatrix ab (device 4).Per op notes, ¿the infected prior meshes (device 1,2,3) and enterocutaneous fistula were noted.The adhesions of bowel to fistula were lysed.The fistula was debrided.The infected part of meshes (device 1,2,3) were excised.A part of small bowel adherent to infected mesh was transected.The hernia defect was repaired using xenmatrix ab (device 4) and sutured.¿.

• 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: 8148702
• Report Number: 1213643-2018-04558
• Device Sequence Number: 1997619
• Product Code: FTL
• UDI-Device Identifier: 00801741016400
• UDI-Public: (01)00801741016400(17)140728(10)HUVG1579
• 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: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 07/28/2014
• Device Catalogue Number: 0010213
• Device Lot Number: HUVG1579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2011
• 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: 67 YR
• Patient Sex: Male