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

Catalog Number	0010215
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Material Deformation (2976)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Scar Tissue (2060); Hernia (2240)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided by the attorney and review of limited medical records provided, no conclusion can be made as to the degree to which the ventrio mesh implant may have caused or contributed to the patient's postoperative course.Infection, pain, adhesions, and recurrence are known inherent risks of surgery/use of the device and are identified in the adverse reactions section of the instructions-for-use supplied with the device as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.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 - sample discarded.
Event or Problem Description
Alleged per legal claim: (b)(6) 2017 - patient was implanted with a ventrio hernia patch.(b)(6) 2022 - patient experienced severe abdominal pain where the mesh was inserted, accompanied by a fever and could barely walk.It is also alleged that the patient's general state of health deteriorated noticeably.(b)(6) 2022 - "it was determined that the implanted mesh was not intact and had to be surgically removed.The operation revealed the mesh had shrunk and had grown together with the body's own abdominal mesh." " the mesh was then removed during the operation.The doctors explained to my client that parts of the implant could not be removed due to the adhesion that had already occurred and that my client would no longer be free of pain." attorney for the patient alleges the device was "faulty" and the patient suffers from recurring unbearable pain.Per limited medical records (doctor's notes) provided: 2017 - patient was diagnosed with supraumbilical recurrent incisional hernia and underwent ipom surgery.(b)(6) 2022 - during hospital stay, the patient received antibiotic therapy for suspected mesh infection; an indication for revision surgery was made due to persistent complaints.(b)(6) 2022 - patient presented with severe pain in the implant site several times; a ct revealed suspected recurrent incisional hernia and distended tissue around the mesh.Patient underwent incisional hernia repair with explant of the ventrio hernia patch, scar tissue resection and was implanted with a non-bard mesh.(note, no operative notes provided).30-sep-2022 - doctor notes the postoperative course was without complications, the patient is in good general condition.

• Brand Name: VENTRIO 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 ; 8005566756
• MDR Report Key: 18345058
• Report Number: 1213643-2023-00499
• Device Sequence Number: 14835524
• Product Code: FTL
• UDI-Device Identifier: 00801741016424
• UDI-Public: (01)00801741016424
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

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 Catalogue Number: 0010215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 12/18/2023
• 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: 39 YR
• Patient Sex: Female