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	Unspecified Infection (1930); Sepsis (2067); Disability (2371)
Date of Event	03/16/2006
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, sepsis, and surgical intervention; however, no details have been provided.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 prosthesis.An unresolved infection may require removal of the prosthesis." this emdr represents the bard/davol composix mesh e/x (device #2).An additional emdr was submitted to represent the bard/davol perfix plug (device #1).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for repair of a left indirect inguinal hernia on or about (b)(6) 2003, a bard/davol perfix plug was implanted to repair the hernia defect.On or about (b)(6) 2003 the patient underwent additional surgery to repair the recurrent left inguinal hernia.It is alleged that the patient underwent additional surgery involving an exploration of wound sinus, resection of infected mesh and suture repair of hernia on or about (b)(6) 2004.On or about (b)(6) 2005 the patient underwent surgery for repair of an incisional hernia and a bard/davol composix e/x was implanted to repair the hernia defect.Attorney alleges that the patient underwent a removal of abdominal wall mesh after presenting with a sinus draining and sepsis on or about (b)(6) 2006.On or about (b)(6) 2007 the patient underwent additional surgery to repair an incisional hernia.It is alleged that the patient was injured severely and permanently.It is alleged that the patient suffered pain, disability, hospitalizations and additional surgeries.The patient has suffered and will continue to suffer physical pain and mental anguish, chronic pain, psychological stress, depression and has undergone and will likely require in the further other forms of care and medical treatments.It is further alleged 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: 10731803
• Report Number: 1213643-2020-09664
• Device Sequence Number: 3483472
• 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: 2005
• Device Explanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2020

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: 09/28/2009
• Device Catalogue Number: 0123460
• Device Lot Number: 43IOD266
• 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: 10/24/2020
• 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; Life Threatening; Required Intervention; Disability