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

Catalog Number	0010213
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Injury (2348); Disability (2371)
Date of Event	01/03/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.No medical records have been provided.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol ventrio (device #2).An additional emdr was submitted to represent the bard/davol perfix plug (device #1).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: on (b)(6) 2010:the patient underwent surgery for implant of an unspecified bard/davol perfix plug (device #1) and an unspecified bard/davol ventrio (device #2).On (b)(6) 2011: the patient had unspecified injuries.The patient is making a claim for an adverse patient outcome against the perfix plug (device #1) and ventrio (device #2).The 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.".
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6)2010: the patient underwent surgery for implant of an unspecified bard/davol perfix plug (device #1) and an unspecified bard/davol ventrio (device #2).(b)(6)2011: the patient had unspecified injuries.The patient is making a claim for an adverse patient outcome against the perfix plug (device #1) and ventrio (device #2).The 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)2010 - patient was diagnosed with umbilical hernia and bilateral inguinal hernia thereby underwent laparoscopic repair with the implant of ventrio mesh (device #1) for umbilical hernia and open repair with the implant of two perfix plug (device #2 - right, device #3 - left) for bilateral inguinal hernia.Per operative notes, ¿umbilical hernia was identified.A circular piece of ventrio mesh (device #1) was secured by tackers.Right direct inguinal hernia was repaired using a perfix plug (device #2) in the internal ring and patch was placed onto the pubic tubercle to inguinal ligament.The procedure was repeated on left direct inguinal hernia using perfix plug (device #3).¿ (b)(6)2011 - patient had bilateral inguinal pain thereby underwent open repair with the partial removal of meshes (device #2, device #3).Per operative notes, ¿the meshes (device #2, #3) were not completely removed.The area was noted to be severely scarred.This was done on both sides of the inguinal regions.¿ (b)(6)2014 - patient had left upper quadrant abdominal pain and adhesion thereby underwent laparoscopic repair.Per operative notes, ¿adhesions to the abdominal wall were taken down.The ventrio mesh (device #1) was placed for umbilical hernia was identified.There was an interloop adhesions to the small bowel in pelvis.¿ attorney alleges that the patient had adhesions and pain.
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.No medical records have been provided.Information is limited at this time.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of event.Based on the additional information provided, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 3 years 6 months post implant of ventrio mesh, patient was diagnosed with adhesion and abdominal pain thereby underwent repair.The instructions-for-use supplied with the device list pain and adhesions as a possible complications.Review of manufacturing records confirms product was manufactured to specification.Note the manufacturing date (15-jan-2010) is considered to be a best estimate.Updated fields: a2, b2, b4, b5, b6, b7, d1, d4 (product catalog no., corporate lot no., expiry date, udi no.), g1, g3, g6, h2, h4, h6, h10, h11.Corrected field: b3 (date of event).This supplemental emdr represents the ventrio mesh (device #1).An additional supplemental emdr was submitted to represent the perfix plug (device #2) and additional emdr was submitted to represent the perfix plug (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.; 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: 7955517
• Report Number: 1213643-2018-03488
• Device Sequence Number: 13791956
• Product Code: FTL
• UDI-Device Identifier: 00801741016400
• UDI-Public: (01)00801741016400(17)110728(10)HUUA0259
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 07/28/2011
• Device Catalogue Number: 0010213
• Device Lot Number: HUUA0259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2010
• 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