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

Catalog Number	5954460
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	03/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 2 years post implant of ventralight st mesh, patient was diagnosed with obstruction, adhesions and abdominal pain thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists adhesions and pain as possible complications.This emdr represents ventralight st (device #3).An additional supplemental emdr was submitted to represent ventrio st (device #1) and an emdr was submitted to represent sorbafix enhanced (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.H3 other text: not returned.
Event or Problem Description
Per additional information provided: on (b)(6) 2014 - patient was diagnosed with umbilical hernia thereby underwent laparoscopic repair with the implant of ventrio st mesh (device #1) and sorbafix enhanced (device #2).Per operative notes, ¿the hernia was measured, a ventrio st mesh (device #1) was then placed into the abdominal wall and tacked with sorbafix enhanced (device #2)." on (b)(6) 2015 - patient was diagnosed with abdominal pain, recurrent hernia thereby underwent open repair with the removal of mesh (device#1), sorbafix enhanced (device#2) and implant of ventralight st mesh (device#3).Per operative notes, ¿if could take out the mesh and the tacks, may be his pain would go away, particularly if removal of the tacks.The mesh was dissected off posteriorly and noted that inferior of the mesh had already pulled away from the fascia and the hernia was recurring.All the mesh (device #1) and tacks (device #2) were removed.A ventralight st mesh (device#3) was then placed into the abdomen." on (b)(6) 2017 - patient was diagnosed with abdominal pain and intra-abdominal adhesions to the mesh and bowel obstruction thereby underwent open repair with the removal of mesh (device #3).Per operative notes, ¿some adhesions to the mesh, attached to the bowel was taken down.The mesh (device #3) was removed." attorney alleges that the patient had adhesions, bowel obstruction, pain, hernia recurrence and emotional injuries.

• Brand Name: VENTRALIGHT ST 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: 20618838
• Report Number: 1213643-2024-094804
• Device Sequence Number: 7353814
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(17)160728(10)HUYH0092
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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: 07/28/2016
• Device Catalogue Number: 5954460
• Device Lot Number: HUYH0092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/06/2024
• 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: 28 YR
• Patient Sex: Male
• Patient Weight: 136 KG