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

Catalog Number	0010219
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); Injury (2348); Disability (2371); Fibrosis (3167)
Date of Event	04/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient¿s attorney alleged, that the ventrio mesh, lot huub0023 was implanted in (b)(6) 2001, however, this may be an erroneous implant date, as the ventrio device was not on the market in 2001 and the reported lot number (valid for the reported ventrio mesh) was manufactured in feb2010.Based on the currently available data, we are unable reconcile the data as reported; therefore, we are reporting the complaint as alleged.At this time no conclusion can be made as to the bard/davol ventrio and no specific device failure was alleged by the attorney.The information provided alleges that the patient underwent an additional surgery to explant the device and the surgeon had to resect a portion of the patient's bowel.However, no medical records were provided and no clarification regarding of reason for explant or the alleged bowel resection has been provided.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Information is limited at this time, should additional information become available, and supplemental emdr will be submitted.Note: the information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2001: the patient underwent repair of an incisional ventral hernia.A bard/davol ventrio mesh patch 16 x 31 cm, lot no.Huub0023 was implanted in the patient during this repair on (b)(6) 2017: the patient underwent removal of the failed bard/davol ventrio mesh.During the procedure, the surgeon had to resect a portion of the patient's bowel in order to release the failed bard/davol ventrio mesh.The attorney alleges that the bard/davol ventrio mesh is defective.The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, and impairment.
Additional Manufacturer Narrative
The patient¿s attorney alleged, that the ventrio mesh, lot huub0023 was implanted in (b)(6) 2001, however, this may be an erroneous implant date, as the ventrio device was not on the market in 2001 and the reported lot number (valid for the reported ventrio mesh) was manufactured in feb2010.Based on the currently available data, we are unable reconcile the data as reported; therefore, we are reporting the complaint as alleged.At this time no conclusion can be made as to the bard/davol ventrio and no specific device failure was alleged by the attorney.The information provided alleges that the patient underwent an additional surgery to explant the device and the surgeon had to resect a portion of the patient's bowel.However, no medical records were provided and no clarification regarding of reason for explant or the alleged bowel resection has been provided.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Information is limited at this time, should additional information become available, and supplemental emdr will be submitted.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of implant and pma/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.Note, the manufacturing date (15-feb-2010) is considered to be a best estimate.Updated fields: a2, a4, b4, b5, b6, b7, d4 (product catalog no., corporate lot no, expiry date, udi no.), g1, g3, g6, h2, h4, h6, h10, h11.Corrected field: d6a (date of implant), pma/510(k) #.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
The following was alleged by the patient's attorney: (b)(6) 2001: the patient underwent repair of an incisional ventral hernia.A bard/davol ventrio mesh patch 16 x 31 cm, lot no.Huub0023 was implanted in the patient during this repair.(b)(6) 2017: the patient underwent removal of the failed bard/davol ventrio mesh.During the procedure, the surgeon had to resect a portion of the patient's bowel in order to release the failed bard/davol ventrio mesh.The attorney alleges that the bard/davol ventrio mesh is defective.The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, and impairment.Addendum per additional information provided: (b)(6) 2011 ¿ patient was diagnosed with ventral hernia thereby underwent open repair with implant of ventrio mesh.Per operative notes, ¿the sac was excised and ventrio mesh was placed and tacked and sutured.¿ (b)(6) 2011 ¿ patient was diagnosed with infected wound thereby underwent open repair with debridement of wound.Per operative notes, ¿the previously placed mesh was seen well incorporated and exposed.The wound was sealed with wound vac and closed.¿ (b)(6) 2017 - patient was diagnosed with infected mesh due to entero mesh fistula thereby underwent open repair with removal of mesh and entero mesh fistula.Per operative notes, ¿the entire mesh with adhesions were removed.The abdominal wall was closed with 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: 7880359
• Report Number: 1213643-2018-03134
• Device Sequence Number: 1758139
• Product Code: FTL
• UDI-Device Identifier: 00801741016462
• UDI-Public: (01)00801741016462
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 07/28/2021
• Device Catalogue Number: 0010219
• Device Lot Number: HUUB0023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2010
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 63 KG