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

Catalog Number	0123810
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Disability (2371)
Date of Event	04/29/2014
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, adhesions, abdominal pain and surgical intervention.The instructions-for-use supplied with the device lists adhesions as a possible complication.In regards to the infection, the warning 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 mesh." should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for repair of an incisional left ventral hernia on or about (b)(6) 2007, a composix e/x was implanted to repair the hernia defect.The patient underwent an additional operation on or about (b)(6) 2014 to remove the infected mesh.It is alleged that the patient underwent a further operation on or about (b)(6) 2015 to remove the remaining composix e/x mesh and deal with adhesion that had occurred due to the mesh.It is alleged that the patient experienced significant physical, psychological and emotional pain and suffering, undergone surgeries and hospitalizations, and has sustained permanent and debilitating injuries, disability and pain.The patient has suffered and continues to suffer from chronic abdominal pain, as well as significant psychological stress and depression.The patient has undergone and will likely require in the further other forms of care and medical treatments.Attorney alleges that the device 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: 10694757
• Report Number: 1213643-2020-09485
• Device Sequence Number: 3174437
• Product Code: FTL
• UDI-Device Identifier: 00801741031212
• UDI-Public: (01)00801741031212
• 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: 2007
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2020

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: 09/28/2011
• Device Catalogue Number: 0123810
• Device Lot Number: 43IQD318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/18/2020
• 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