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); Swelling (2091); Disability (2371)

Event Date 04/17/2015

Event Type  Injury  

Manufacturer Narrative

Based on the information provided it appears the patient was treated with two unspecified perfix plug for bilateral inguinal hernia repairs and a non-bard davol mesh for an umbilical hernia repair.This file represents the left sided hernia repair device.At this time general allegations were made against all "products" implanted in the patient.There are no specific interventions alleged related to the left inguinal hernia repair device.To date no medical records have been provided.Without a lot number a review of the manufacturing records could not be conducted.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.Another file was created to address the right sided hernia repair product.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.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 to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2008 - the patient was diagnosed with left and right inguinal hernia and umbilical hernia.The patient underwent a repair of the hernias with mesh, plug and patch technique.During the operation, the patient was implanted with mesh (covidien parietex) and unspecified bard/davol perfix plug (x2).On (b)(6) 2015 - the patient was diagnosed with recurrent right inguinal hernia.Patient underwent repair of recurrence right inguinal hernia, incarcerated with mesh.The attorney alleges the patient experienced defective mesh, permanent injury, abdominal pain, swelling, ambulation difficulty and additional surgical procedures.

• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6568932
• MDR Text Key: 75277043
• Report Number: 1213643-2017-00310
• 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: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• 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: 04/25/2017
• 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