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); Unspecified Infection (1930); Sepsis (2067)

Event Date 12/16/2016

Event Type  Death  

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.Regarding infection; the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed." no lot number has been provided; therefore a review of the manufacturing records is not possible at this time.No medical records, autopsy, or death certificate have been provided.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 Description

The following was alleged by the patient's attorney: (b)(6) 2016: the patient underwent surgical hernia repair, which included the implantation of bard/davol composix e/x.The patient had been cleared for surgery in the days or weeks preceding (b)(6) 2016.Ni/ni/ni: subsequent to the surgical procedure, the patient began experiencing adverse reactions and side effects including without limitation, constant and severe abdominal pain, increasing abdominal distention and abdominal girth, wound dehiscence, intra-abdominal post-surgical infection, sepsis, and atrial fibrillation.On (b)(6) 2016, the patient was seen on various occasions by multiple health care providers and underwent various tests and procedures in an attempt to alleviate, among other things, the abdominal pain, abdominal distention and abdominal girth, wound dehiscence intra-abdominal infection, sepsis and atrial fibrillation, to discern their cause.Such visits, procedures and tests included, without limitations, doctor visits, emergency room visits, and wound care visits.On (b)(6) 2016: the patient died, his death certificate listing the cause of death as septic shock, intra-abdominal infection and ventral abdominal hernia.The patient was severely and permanently injured, suffered great pain and anguish, sustained severe and disabling injuries, was confined for a period of time, was prevented from continuing his usual course of conduct and was otherwise injured and restricted in his bodily movements, and ultimately, was caused to suffer an untimely death.The patient was caused to sustain and suffer severe emotional distress, mental anguish, suffering, anxiety, stress, depression, and disability.The mesh implanted in the patient failed to reasonably perform as intended.The mesh caused serious injury to the patient and ultimately, the patient's untimely 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: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652659
• MDR Report Key: 8308627
• MDR Text Key: 135131119
• Report Number: 1213643-2019-00686
• 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
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• 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
• Date Manufacturer Received: 01/22/2019
• 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; Disability