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

Catalog Number 0117160

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

Patient Problems Inflammation (1932); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422)

Event Date 08/25/2015

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, hernia recurrence, bowel obstruction, pain and surgical intervention.The instructions-for-use (ifu) supplied with the device lists hernia recurrence, pain and inflammation as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that the patient was implanted with a bard/davol perfix light plug medium (the product).It is alleged that on (b)(6) 2013, the patient was implanted with the product in the course of an inguinal hernia repair surgery.It is alleged that further to the patient's implantation with the product, patient suffered the development of chronic pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, and hernia recurrence, necessitating further reparative surgery which occurred on (b)(6)2015.It is alleged that subsequent to the latter surgery, the patient has continued to suffer from chronic pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, and hernia recurrence.Attorney alleges that the patient 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 that the patient experienced severe pain and suffering, including chronic pain.Attorney alleges that the patient has been treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics, and rest.It is alleged that the patient will require further invasive repair surgery, physiotherapy, rehabilitation, and will continue to require other medical care in the foreseeable future.It is also 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: 13586786
• MDR Text Key: 289179841
• Report Number: 1213643-2022-91312
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030994
• UDI-Public: (01)00801741030994
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2022

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 Expiration Date: 02/28/2018
• Device Catalogue Number: 0117160
• Device Lot Number: HUXB1357
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2013
• 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): Disability; Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Male