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

Catalog Number	5954790
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	04/24/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.As reported during the explant procedure the surgeon noted dense adhesions and pieces of the previously placed mesh at the site of the recurrent hernia.The cause of the adhesions and recurrence of hernia cannot be determined.Adhesions and recurrence of hernia or soft tissue defect are known inherent risks of hernia repair surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complications.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The patient's attorney has alleged the following: (b)(6) 2011- patient underwent laparoscopic repair of a ventral hernia and a bard/davol ventralight st bard mesh was implanted.(b)(6) 2015- the patient was admitted for nausea, vomiting, abdominal pain, and irregular bowels.It was ultimately determined that surgical intervention was necessary.On the same day, the patient underwent surgery to remove the failed mesh and repair a recurrent hernia.During the procedure, the surgeon noted dense adhesions and pieces of the previously placed mesh at the site of recurrent hernia.As alleged, prior to and after this procedure, the patient suffered severe and debilitating pain.The patient also requires further medical treatment, including likely need for future surgeries.The attorney alleges that the patient suffered permanent injuries and significant pain and suffering.
Additional Manufacturer Narrative
At this time no conclusions can be made.As reported during the explant procedure the surgeon noted dense adhesions and pieces of the previously placed mesh at the site of the recurrent hernia.The cause of the adhesions and recurrence of hernia cannot be determined.Adhesions and recurrence of hernia or soft tissue defect are known inherent risks of hernia repair surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complications.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the manufacturing date.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-mar-2011) 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 patient's attorney has alleged the following: (b)(6) 2011- patient underwent laparoscopic repair of a ventral hernia and a bard/davol ventralight st bard mesh was implanted.(b)(6) 2015- the patient was admitted for nausea, vomiting, abdominal pain, and irregular bowels.It was ultimately determined that surgical intervention was necessary.On the same day, the patient underwent surgery to remove the failed mesh and repair a recurrent hernia.During the procedure, the surgeon noted dense adhesions and pieces of the previously placed mesh at the site of recurrent hernia.As alleged, prior to and after this procedure, the patient suffered severe and debilitating pain.The patient also requires further medical treatment, including likely need for future surgeries.The attorney alleges that the patient suffered permanent injuries and significant pain and suffering.Addendum per additional information provided: (b)(6) 2011 - patient was diagnosed with recurrent ventral hernia with intermittent small bowel obstruction thereby underwent laparoscopic repair with the implant of ventralight st mesh.Per operative notes, "the abdominal wall defect was identified and the adhesions were noted and taken down.The hernia defect was noted and a ventralight st mesh was placed and sutured." (b)(6) 2015 - patient was diagnosed with recurrent incarcerated ventral incisional hernia and adhesions thereby underwent open repair with removal of mesh and implant of synthetic mesh.Per operative notes, "the sac was dissected, the mesh was removed.The fascial defect was noted and a synthetic mesh was placed in an underlay fashion sutured.".

• Brand Name: VENTRALIGHT ST 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 ; 4018258605
• MDR Report Key: 8129034
• Report Number: 1213643-2018-04358
• Device Sequence Number: 1653204
• Product Code: FTL
• UDI-Device Identifier: 00801741031663
• UDI-Public: (01)00801741031663(17)130328(10)HUVC1441
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 05/22/2025

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: 03/28/2013
• Device Catalogue Number: 5954790
• Device Lot Number: HUVC1441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2011
• 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: Hospitalization; Disability; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female