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

Catalog Number UNKAA053

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

Patient Problems Pain (1994); Disability (2371); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Based on the information provided there is no connection that can be at this time between the allegations made by the patient's attorney and any problem with the bard/davol device used to treat the patient's hernia.The patient's attorney did not allege a specific device failure and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records could not be conducted.Should additional information be provided, a supplemental emdr will be submitted.This file represents the bard perfix plug, an additional emdr has been submitted to document the alleged implant of the bard ventralex st mesh.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2014 - the patient underwent the repair of the left inguinal hernia with mesh, plug and patch technique.The attorney alleges during the implant procedure the patient was implanted with a bard/davol perfix plug and a bard/davol ventralex st mesh.The attorney for the patient alleges the patient has experienced severe and permanent bodily injuries, including but not limited to excruciating abdominal pain and swelling, difficulty walking and physical pain and alleges the patient will have to undergo additional surgery to "remove and/or repair the damage and injuries caused by the products." the attorney further alleges the products are defective and the patient to have suffered future loss of enjoyment of life, permanent injury, permanent scarring and disfigurement.

• 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
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7104881
• MDR Text Key: 94471074
• Report Number: 1213643-2017-01004
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2017
• 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): Required Intervention; Disability