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 Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

At this time, no conclusions can be made to what extent the bard/davol xenmatrix ab(device #2) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.The patient's attorney alleges subsequent surgical intervention; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol xenmatrix ab (device #2).An additional emdr was submitted to represent the bard/davol ventralex (device #1).Not returned.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2016 or (b)(6) 2017: the patient underwent surgery for implant of an unspecified bard/davol ventralex (device #1) and unspecified bard/davol xenmartrixab (device #2).Ni/ni/ni:the patient had subsequent surgical intervention due to the hernia mesh device(s).The patient is making a claim for an adverse patient outcome against the bard/davol ventralex (device #1) and the xenmartrixab (device#2).The attorney alleges patient experienced emotional distress and the device was 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: 8383863
• MDR Text Key: 137663323
• Report Number: 1213643-2019-01222
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• 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: 02/10/2019
• 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