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

Catalog Number	0010214
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240); Injury (2348)
Date of Event	04/23/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventrio st (device #2) used to treat the patient.The patient's attorney did allege injury and surgical intervention; 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 ventralex (device #1).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventralex hernia patch (device #1) or an unspecified bard/davol ventrio st (device #2) on (b)(6) 2009 or (b)(6) 2009.Attorney alleges unspecified injuries.As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventralex hernia patch (device #1) and the bard/davol ventrio st (device #2).It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the attorney alleges patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol ventrio st (device #2) used to treat the patient.The patient's attorney did allege injury and surgical intervention; 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 brand name and 510(k).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.Updated fields: a2, b3, b4, b5, b6, b7, d4 (product catalog no., corporate lot no., udi no.), d6.A (date of implant), d6.B (date of explant), g1, g3, g6, h2, h6, h10, h11.Corrected field: d1 (brand name), g4 (pma/510(k) #).This supplemental emdr represents the bard/davol ventrio mesh (device #1).An additional supplemental emdr was submitted to represent the bard/davol mesh - ventralex (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
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventralex hernia patch (device #1) or an unspecified bard/davol ventrio st (device #2) on (b)(6) 2009.Attorney alleges unspecified injuries.As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventralex hernia patch (device #1) and the bard/davol ventrio st (device #2).It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2009 - patient was diagnosed with incarcerated ventral incisional hernia thereby underwent laparoscopic repair with the implant of ventrio patch (device #1).Per op notes, ¿a ventrio patch was placed into the abdominal cavity and then sutured to the anterior abdominal wall.¿ (b)(6) 2009 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of ventralex mesh (device #2).Per op notes, ¿a ventralex mesh (device #2) was secured to the fascial edges with sutures.¿ (note: the previously placed ventrio patch (device #1) was not seen during this procedure) (b)(6) 2010 - patient was diagnosed with recurrent ventral incisional hernia and chronic abdominal pain thereby underwent repair with removal of mesh (device #1 & #2).Per op notes, ¿dense adhesions to the anterior abdominal wall and a recurrent ventral incisional hernia with incarcerated small bowel and the bladder is stretched up to the mesh by adhesions.¿.

• 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: 9147091
• Report Number: 1213643-2019-09678
• Device Sequence Number: 8652390
• Product Code: FTL
• UDI-Device Identifier: 00801741016417
• UDI-Public: (01)00801741016417(10)DASK0012
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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 Catalogue Number: 0010214
• Device Lot Number: DASK0012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 07/11/2025
• 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: 30 YR
• Patient Sex: Female