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

Catalog Number UNKAA015

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

Patient Problems Death (1802); Injury (2348)

Event Type  Death  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol composix e/x may have caused or contributed to the reported event.The patient's attorney alleges wrongful death; however no medical records, autopsy, or death certificate 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) 2005: the patient underwent surgery for implant of an unspecified bard/davol composix e/x.Ni/ni/ni: the patient had subsequent surgical intervention due to the hernia mesh device.The patient is making a claim for an adverse patient outcome against the composix e/x.The attorney alleges product is defective and that the patient experienced emotional distress.The attorney alleges wrongful death.

Manufacturer Narrative

Addendum to previous information.This supplemental emdr is being sent to correct the field (type of reportable event) to death.Should additional information be provided a supplemental emdr will be submitted.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2005: the patient underwent surgery for implant of an unspecified bard/davol composix e/x.Ni/ni/ni: the patient had subsequent surgical intervention due to the hernia mesh device.The patient is making a claim for an adverse patient outcome against the composix e/x.The attorney alleges product is defective and that the patient experienced emotional distress.The attorney alleges wrongful death.

• Brand Name: COMPOSIX E/X
• 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: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 8379491
• MDR Text Key: 137453394
• Report Number: 1213643-2019-01180
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002684
• 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,Followup
• Report Date: 03/06/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA015
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 03/06/2019
• 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): Death; Required Intervention