MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX AB; SURGICAL MESH

Catalog Number UNKAA105

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Injury (2348); Disability (2371)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.The patient's attorney alleges unspecified injuries; however, no details have been provided regarding the nature of the injury and for the additional surgery for explant of the device.No medical records have been provided.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2015:the patient was diagnosed with a ventral hernia and underwent ventral hernia repair with a bard/davol xenmatrix ab surgical graft product.In the months following the (b)(6) 2016 explant of the bard/davol xenmatrix ab surgical graft, the patient continued to experience chronic abdominal pain, and further experiences several medical issues in which the patient is currently seeking additional medical treatments for.As a result of having the product (bard/davol xenmatrix ab surgical graft), the patient has experienced significant mental and physical pain and suffering and mental anguish, has sustained permanent injury, has undergone medical treatment and/or corrective surgery hospitalization and will likely undergo further medical treatment and procedures.It is alleged that the bard/davol xenmatrix ab surgical graft product is defective.

• Brand Name: XENMATRIX AB
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: jan ling ; 100 crossings blvd.; warwick, RI 02886 ; 8015652663
• MDR Report Key: 8034996
• MDR Text Key: 126015370
• Report Number: 1213643-2018-03830
• Device Sequence Number: 1
• Product Code: PIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability