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

Catalog Number 0112760

Device Problems Defective Device (2588); Material Protrusion/Extrusion (2979); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Disability (2371)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

The cause of the patient's post-operative complications cannot be determined at this time.Should additional information be provided, a supplemental emdr will be submitted.Note: not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2008 - the patient underwent repair of right inguinal hernia as well as repair of right inguinal hernia.A perfix plug was implanted in the patient during this repair.As reported by the patient's attorney, over the next several years, the bard/davol perfix plug caused the patient to experience significant pain and physical impairment.The patient experienced severe and chronic pain and swelling in the area as a result of the bard/davol perfix plug.The patient suffered significant physical impairment and was unable to conduct many daily physical activities as a result of the bard/davol perfix plug.Complications with the bard/davol perfix plug caused the patient to seek medical treatment and assessment on numerous occasions.It was discovered that the subject mesh was protruding into the abdominal cavity and causing the patient pain and physical impairment.On (b)(6) 2017- the patient underwent laparoscopic right inguinal hernia repair.During the procedure, the operating surgeon removed some or all of the bard/davol perfix plug and repaired the area.The patient's attorney alleges that the bard/davol perfix plug implanted in the patient was defective and that the patient has suffered permanent injuries and significant pain and suffering.

Manufacturer Narrative

The cause of the patient's post-operative complications cannot be determined at this time.Should additional information be provided, a supplemental emdr will be submitted.This emdr updates and corrects the following field device manufacture date.Not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2008 - the patient underwent repair of right inguinal hernia as well as repair of right inguinal hernia.A perfix plug was implanted in the patient during this repair.As reported by the patient's attorney, over the next several years, the bard/davol perfix plug caused the patient to experience significant pain and physical impairment.The patient experienced severe and chronic pain and swelling in the area as a result of the bard/davol perfix plug.The patient suffered significant physical impairment and was unable to conduct many daily physical activities as a result of the bard/davol perfix plug.Complications with the bard/davol perfix plug caused the patient to seek medical treatment and assessment on numerous occasions.It was discovered that the subject mesh was protruding into the abdominal cavity and causing the patient pain and physical impairment.(b)(6) 2017- the patient underwent laparoscopic right inguinal hernia repair.During the procedure, the operating surgeon removed some or all of the bard/davol perfix plug and repaired the area.The patient's attorney alleges that the bard/davol perfix plug implanted in the patient was defective and that the patient has suffered permanent injuries and significant pain and suffering.

• Brand Name: PERFIX PLUG
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8165120
• MDR Text Key: 130362538
• Report Number: 1213643-2018-04762
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608
• Combination Product (y/n): N
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2013
• Device Catalogue Number: 0112760
• Device Lot Number: HUSG0505
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability