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

Catalog Number	5950080
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	09/17/2018
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, hernia, adhesions, bowel injury, hematoma and recurrence.The instructions-for-use supplied with the device lists adhesions, hematoma and recurrence as possible complications.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for a repair of a midline incisional hernia and a bard/davol ventrio st hernia patch was implanted on or about (b)(6) 2015.The patient underwent revision surgery of the ventrio st and was implanted with non-bard/davol mesh to repair a recurrent hernia on or about (b)(6) 2018.The patient underwent revision surgery of the mesh products on or about (b)(6) 2018.It is alleged that the patient continues to experience complications related to the mesh products, including severe and chronic pain/discomfort, adhesions to the bowel, bowel blockage, hematoma, and recurrence, and will likely require additional surgeries to repair the damage from the mesh products if the complications continue.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the device was defective.

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11380657
• Report Number: 1213643-2021-01311
• Device Sequence Number: 3865933
• Product Code: FTL
• UDI-Device Identifier: 00801741031571
• UDI-Public: (01)00801741031571
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 12/28/2015
• Device Catalogue Number: 5950080
• Device Lot Number: HUXL0810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/25/2021
• 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