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

Catalog Number	0010216
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	09/11/2013
Type of Reportable Event	Serious Injury
Additional 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, subsequent surgical intervention, infection, bowel obstruction, hernia recurrence and fistula.The instructions-for-use supplied with the device lists hernia recurrence, adhesions, fistula formation and inflammation as possible complications.In regards to the infection, the warnings section of the ifu states " if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that on or about (b)(6) 2009, a non-bard/davol mesh was implanted in the patient's abdomen to repair an incisional hernia.The patient underwent repair of a recurrent hernia on or about (b)(6) 2013.A bard/davol ventrio mesh patch was implanted during this repair.The patient underwent removal of the mesh products on or about (b)(6) 2013.It is alleged that the patient experienced and/or continues to experience severe and chronic pain, inflammation, adhesions, bowel obstruction, recurrence, surgery to remove mesh, infection, fistula, abdominal wall reconstruction, and open draining wound, which have impaired the patient's activities of daily living and continues to suffer complications as a result of being implanted with the mesh products.The ventrio mesh caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the ventrio mesh was initially implanted to treat.The attorney alleges past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries, permanent impairment, mental pain and suffering sustained by the patient.It is also alleged that the device was defective.

• Brand Name: VENTRIO MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10499171
• Report Number: 1213643-2020-07920
• Device Sequence Number: 437051
• Product Code: FTL
• UDI-Device Identifier: 00801741016431
• UDI-Public: (01)00801741016431
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2020

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: 10/28/2015
• Device Catalogue Number: 0010216
• Device Lot Number: HUWJ0964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability