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

Catalog Number 0112970

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

Patient Problems Hernia (2240); Injury (2348); Disability (2371)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

To date, limited information has been provided. Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged. Hernia recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication. This emdr is reflective of the information for device # 2, a separate emdr will be filed for device #2. Review of the device history records found lot was manufactured to specification, no anomalies identified. If additional information is obtained, a supplemental mdr will be submitted. Not returned.

Event Description

It is alleged by the patients attorney that on (b)(6) 2013, the patient underwent surgery for repair of bilateral inguinal hernias. As reported, two bard/davol perfix plugs, (b)(4), lot number huwf2454 (device # 1) and (b)(4), lot number huwi1301 (device # 2) were implanted to repair the hernia defects. It is alleged that on (b)(6) 2015, the patient underwent an additional surgery to repair the hernia defect and add two bard/davol 3dmax implants. It necessitated the "removal of the patient's lower pelvis to fixate. " as alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective perfix plugs.

• 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: jessica messier ; 100 crossings blvd.; warwick, RI 02886 ; 4018258720
• MDR Report Key: 7143927
• MDR Text Key: 95724004
• Report Number: 1213643-2017-01107
• 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: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/28/2017
• Device Catalogue Number: 0112970
• Device Lot Number: HUWI1301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/22/2017 Patient Sequence Number: 1