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

Catalog Number 5955460

Device Problems Migration or Expulsion of Device (1395); Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Insufficient Information (4580)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, adhesion, chronic pain and subsequent surgical intervention for mesh removal.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that the patient was implanted with a non-bard/davol mesh and a bard/davol ventralight st mesh w/ echo ps (mesh products).Attorney alleges that on or about (b)(6) 2011, the patient was implanted with a non-bard/davol mesh to repair a ventral hernia.It is alleged that on or about (b)(6) 2017, the patient underwent recurrent ventral hernia repair, removal of the non-bard/davol mesh and was implanted with a bard/davol ventralight st mesh w/ echo ps."as a direct and proximate result of defendants¿ defective design, manufacture, marketing, distribution, and/or sale of non-bard/davol mesh and the ventralight st mesh w/ echo ps and placing the defective products into the stream of commerce, the patient has been injured and damaged as follows": it is alleged that on or about (b)(6) 2021, the patient underwent revision of the bard/davol ventralight st mesh w/ echo ps.It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, mesh migration, mesh curling, dense adhesions, loops of bowel adhered to mesh, recurrence, and mesh removal.It is alleged that the patient continues to suffer complication as a result of implantation with the mesh products.It is alleged that the patient at a higher risk of severe complications during abdominal surgery, to the extent that future abdominal operations might not be feasible.It is alleged that the patient has suffered and will continue to suffer physical pain and suffering, as well as mental anguish and emotional distress.It is also alleged that the patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, impairment.Attorney alleges "past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient and permanent impairment.".

• Brand Name: VENTRALIGHT ST W/ ECHO
• Type of Device: 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: 14569100
• MDR Text Key: 293274551
• Report Number: 1213643-2022-94269
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Catalogue Number: 5955460
• Device Lot Number: HUAY1799
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Sex: Male