MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM 4.5INCH CIRCLE; MESH, SURGICAL, POLYMERIC

Catalog Number 59855450

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2022

Event Type  Injury  

Event Description

Hernia repair with ventralight st mesh with the echo ps positioning system.After the first of two mesh was implanted, the surgeon noted the [invalid]on the second mesh was loose and sliding along the [invalid] after the second mesh was secured in the body cavity, the green positioning device was deflated and they cut the positioning device, and removed it.Upon removal, it was noticed that the yellow anchor was not present on the [invalid] after an extensive search of the abdomen, including removal of most of the sewn in mesh, the surgeon located the yellow anchor in the subcutaneous tissue above the mesh.It was immediately removed from the body and secured in a biohazard bag to send for further investigation.It is unclear which ventralight st mesh was defective, so both boxes of the mesh were pulled.The reference number for the two meshes: (b)(4).One lot number is: hufw2004, another is: huft0609.Fda safety report id # (b)(4).

Event Description

Hernia repair with ventralight st mesh with the echo ps positioning system.After the first of two mesh was implanted, the surgeon noted the [invalid]on the second mesh was loose and sliding along the [invalid] after the second mesh was secured in the body cavity, the green positioning device was deflated and they cut the positioning device, and removed it.Upon removal, it was noticed that the yellow anchor was not present on the [invalid] after an extensive search of the abdomen, including removal of most of the sewn in mesh, the surgeon located the yellow anchor in the subcutaneous tissue above the mesh.It was immediately removed from the body and secured in a biohazard bag to send for further investigation.It is unclear which ventralight st mesh was defective, so both boxes of the mesh were pulled.The reference number for the two meshes: (b)(4).One lot number is: hufw2004, another is: huft0609.Fda safety report id # (b)(4).

• Brand Name: BARD VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM 4.5INCH CIRCLE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.
• MDR Report Key: 13499794
• MDR Text Key: 285404543
• Report Number: MW5107311
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/04/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/28/2022
• Device Catalogue Number: 59855450
• Device Lot Number: HUFT0609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White