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

Catalog Number UNKAA018

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Unspecified Infection (1930); Hernia (2240)

Event Date 06/25/2013

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including hernia recurrence, infection, fistula and subsequent surgical intervention for mesh removal.The instructions-for-use (ifu) supplied with the device lists fistula and hernia recurrence as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis." should additional information be provided, a supplemental emdr will be submitted.

Event Description

Attorney alleges that the patient underwent an incisional hernia repair surgery on (b)(6) 2013 and a bard/davol composix mesh was implanted.It is alleged that further to the implantation of the product, the patient suffered the development of fatigue, polydipsia, chronic infection, chronic fistula, chronic pain, fluid accumulation in the abdominal wall, and hernia recurrence.The patient experienced severe pain and suffering, and necessitating a partial mesh removal and revision surgery on (b)(6) 2013.It is alleged that the patient has suffered injuries, losses and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.It is also alleged the patient was treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics and rest.Attorney alleges that the patient will require further invasive repair surgery, physiotherapy, rehabilitation and will continue to require other forms of medical care.It is also alleged that the device was defective.

• Brand Name: MESH COMPOSIX
• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 12322183
• MDR Text Key: 266585702
• Report Number: 1213643-2021-06866
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K971745
• 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: 08/14/2021

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: UNKAA018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/14/2021
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 47 YR