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

Catalog Number 0117180

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

Patient Problems Hematoma (1884); Injury (2348); Disability (2371)

Event Date 11/13/2014

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 permanent injury, hematoma, pain and surgical intervention; however, no details have been provided.The instructions-for-use supplied with the device lists hematoma and pain as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the bard/davol perfix plug light (device #2).An additional emdr was submitted to represent the bard/davol perfix plug light (device #1).Should additional information be provided, a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that on or about (b)(6) 2014, the patient underwent a surgery for the repair of left inguinal hernia and two bard/davol perfix light plugs were implanted to repair the hernia defect.It is alleged that on or about (b)(6) 2014, the patient underwent an additional surgery for excision of a chronic hematoma in the left groin with a primary repair of an inguinal hernia.The patient was injured severely and permanently.Attorney alleges that the patient had pain, disability, hospitalizations and additional surgeries.It is also alleged that the patient suffered and continues to suffer from chronic pain, psychological stress and depression.It is also alleged that the patient has undergone and will likely require in the further other forms of care and medical treatments.It is alleged that the device was defective.

• Brand Name: PERFIX PLUG LIGHT
• 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: 10705455
• MDR Text Key: 212114142
• Report Number: 1213643-2020-09507
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031014
• UDI-Public: (01)00801741031014
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K092032
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Catalogue Number: 0117180
• Device Lot Number: HUXL0182
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2013
• 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