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

Catalog Number	0123810
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Disability (2371)
Date of Event	11/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.It is unknown to what extent the bard/davol composix e/x device may have caused or contributed to the events as alleged by the patient¿s attorney.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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.Not returned.
Event or Problem Description
It is alleged by patient's attorney that on or about (b)(6) 2012, patient underwent surgery for repair of an incisional hernia.As alleged a bard/davol composix e/x, was implanted to repair the hernia defect.It is also alleged by the patient's attorney that on or about (b)(6) 2016, patient underwent an additional operation to repair and/or remove the defected mesh.The patient was injured severely and permanently.As alleged, patient has suffered and will continue to suffer physical pain and mental anguish.As reported, patient has suffered and continues to suffer from chronic pain, as well as psychological stress and depression.Patient has undergone and will likely require in the further other forms of care and medical treatments due to the alleged defective composix e/x hernia patch mesh.

• Brand Name: COMPOSIX 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: 9355642
• Report Number: 1213643-2019-11386
• Device Sequence Number: 2790605
• 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: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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: 06/28/2004
• Device Catalogue Number: 0123810
• Device Lot Number: 43FMD200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/21/2019
• 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