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); Seroma (2069); Disability (2371)
Date of Event	02/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cause of the patient's post-op complications cannot be determined at this time.Seroma and infection are listed in the instructions-for-use as possible complication.Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.No sample returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2016: the patient underwent repair of an incisional hernia.A ventrio mesh patch 22.1cm x 27.1cm, reference number 0010216, lot number huzk0155 was implanted in patient during this repair.On (b)(6) 2016: the patient underwent a procedure for irrigation and debridement of an abdominal wall seroma.On (b)(6) 2016: the patient underwent a procedure for irrigation and debridement of patient's non-healing abdominal wound.On (b)(6) 2017: the patient underwent surgery to explant the infected incisional hernia mesh.On (b)(6) 2017: the patient underwent a procedure for irrigation and debridement of patient¿s non-healing abdominal wound.As alleged, the patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, impairment.

• 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: 8139586
• Report Number: 1213643-2018-04458
• Device Sequence Number: 16549508
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 05/28/2019
• Device Catalogue Number: 0010216
• Device Lot Number: HUZK0155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/06/2018
• 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: Hospitalization; Required Intervention; Disability