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

Catalog Number	5954680
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 1 year 6 months post implant of ventralight st mesh, patient was diagnosed with hernia recurrence, adhesions and abdominal pain thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence, pain and adhesions as possible complications.Review of manufacturing records confirms product was manufactured to specification.This emdr represents the ventralight st mesh (device #2).An additional supplemental emdr was submitted to represent the ventralex st (device #1).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
Addendum per information provided: on (b)(6) 2016: patient was diagnosed with epigastric hernia thereby underwent open repair with implant of ventralex st (device #1).Per operative notes, "herniated preperitoneal fat was immediately encountered and reduced.A 6.4 cm ventralex st mesh (device #1) was placed." on (b)(6) 2017: patient was diagnosed with recurrent intra-abdominal wall hernia and abdominal pain thereby underwent laparoscopic repair with implant of ventralight st mesh (device #2).Per operative notes, "there were omental adhesions attached to the previously placed mesh which were dissected away.It appeared the previously placed mesh had partially migrated from its original position.The mesh was left in place.A piece of ventralight st mesh (device #2) was placed overlap of the repair." on (b)(6) 2018: patient underwent revision surgery with repair of recurrent ventral hernia thereby underwent open repair with removal of mesh.Per operative notes, "midline incision was made and carried down to defect and previously placed mesh.Mesh was densely adherent to underlying omentum.The omentum adherent to the mesh was then resected.The synthetic mesh was secured to posterior fascia superiorly and inferiorly." attorney alleges that the patient had adhesions, mesh migration, infection, pain, hernia recurrence, and emotional injuries.It is also alleged that the patient had surgery on (b)(6) 2017 to repair the recurrent hernia.

• 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: 20649937
• Report Number: 1213643-2024-094812
• Device Sequence Number: 16913396
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656(17)181128(10)HUAX1839
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

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: 11/28/2018
• Device Catalogue Number: 5954680
• Device Lot Number: HUAX1839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2016
• 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: 24 YR
• Patient Sex: Female
• Patient Weight: 150 KG