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

Catalog Number	0123790
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Hernia (2240); Disability (2371)
Date of Event	11/16/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol composix e/x device may have caused or contributed to the reported event.The patient's attorney alleges injuries, subsequent surgery including removal of device, intraperitoneal abscess and abdominal wall debridement; however no details have been provided.Should additional information be provided a supplemental emdr will be submitted.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
It is alleged by the patient's attorney that on or about (b)(6) 2011, 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 alleged by the patient's attorney that on or about (b)(6) 2011, patient underwent an additional surgery for the removal of implanted mesh and drainage of intraperitoneal abscess and abdominal wall debridement.The patient was injured severely and permanently.As reported, patient has experienced significant physical, psychological and emotional pain and suffering, and has sustained permanent and debilitating injuries.Furthermore, despite having procedure, the patient continues to experience problems with hernia defect.As alleged, patient has suffered and continues to suffer from chronic debilitating pain, as well as significant psychological stress and depression.As reported, 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.

• 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: 9089087
• Report Number: 1213643-2019-08994
• Device Sequence Number: 16793732
• Product Code: FTL
• UDI-Device Identifier: 00801741031205
• UDI-Public: (01)00801741031205
• 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: 2011
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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: 06/28/2012
• Device Catalogue Number: 0123790
• Device Lot Number: HURF0295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/19/2019
• 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