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	Adhesion(s) (1695); Inflammation (1932); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	09/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleged revision surgery and injuries, however; no details have been provided.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.Note: not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent surgery for implant of an unspecified bard/davol ventrio.On (b)(6) 2016: the patient had unspecified injuries and underwent revision surgery.The patient is making a claim for an adverse patient outcome against the ventrio.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.The patient's attorney alleged revision surgery and injuries, however; no details have been provided.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.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-2010) is considered to be a best estimate.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) 2011: the patient underwent surgery for implant of an unspecified bard/davol ventrio.(b)(6) 2016: the patient had unspecified injuries and underwent revision surgery.The patient is making a claim for an adverse patient outcome against the ventrio.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) 2011 - patient was diagnosed with incarcerated ventral hernia thereby underwent laparoscopic repair with implant of ventrio mesh.Per operative notes, ¿the incarcerated ventral hernia sac was identified and excised.A ventrio mesh was placed and tacked.¿ (b)(6) 2016 - patient was diagnosed with recurrent umbilical hernia thereby underwent laparoscopic repair with excision of ventrio mesh and implant of synthetic mesh.Per operative notes, ¿the adhesions were taken down.A section of small bowel stuck and attached firmly up to the prior mesh was dissected.The ventrio mesh was removed completely.The hernia defect was identified and repaired with synthetic mesh using prolene sutures.¿.

• 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: 8125927
• Report Number: 1213643-2018-04309
• Device Sequence Number: 1770856
• Product Code: FTL
• UDI-Device Identifier: 00801741016417
• UDI-Public: (01)00801741016417(17)120128(10)HUUG0321
• 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: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: 01/28/2012
• Device Catalogue Number: 0010214
• Device Lot Number: HUUG0321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2010
• 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: 40 YR
• Patient Sex: Female