MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX MESH E/X; SURGICAL MESH

Catalog Number	0123460
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Disability (2371)
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, infection, fistula, and surgical intervention.The instructions-for-use supplied with the device lists fistula as a possible complication.In regards to 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 prosthesis.An unresolved infection may require removal of the prosthesis." this emdr represent bard/davol composix mesh e/x (device #2).An additional emdr was submitted to represent the bard/davol composix mesh e/x (device #1).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that on or about (b)(6) 2006, the patient underwent surgery for repair of an incisional ventral hernia and a composix e/x was implanted to repair the hernia defect.On or about (b)(6) 2006, the patient underwent a further surgery to remove the previously implanted mesh and an another composix e/x was implanted to repair the hernia issue.On or about (b)(6) 2018, the patient had an operation for abdominal wall debridement with removal of stitch granuloma due to issues resulting from the implanted composix e/x.On or about (b)(6) 2019, the patient had a further operation due to infected mesh with erosion through skin, where the mesh was removed.Through this operation it was found that the part of the bowel was incorporated into and in fact was fistulised to the mesh, creating the need for bowel resection.The patient has suffered and will continue to suffer physical pain, mental anguish, chronic pain, psychological stress and depression.It is alleged that the patient has undergone and will likely require in the further other forms of care and medical treatment.It is alleged that the patient had pain, disability, hospitalizations and additional surgeries.It is also alleged that the mesh was defective.

• Brand Name: COMPOSIX MESH E/X
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10680657
• Report Number: 1213643-2020-09403
• Device Sequence Number: 2656142
• Product Code: FTL
• UDI-Device Identifier: 00801741031182
• UDI-Public: (01)00801741031182
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 04/28/2011
• Device Catalogue Number: 0123460
• Device Lot Number: 43DQD331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/14/2020
• 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: Hospitalization; Required Intervention; Disability