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)

Patient Problems Unspecified Infection (1930); Disability (2371); Obstruction/Occlusion (2422)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol perfix plug (device #2) device may have caused or contributed to the reported event.The attorney alleges the patient underwent an additional surgery for infections, intestinal blockage, recurrent hernia and to remove the device that was protruding through the abdominal wall.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.Regarding infection; the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed." a manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol perfix plug (device #2).An additional emdr was submitted to represent the bard/davol perfix plug (device #1).Note: not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent a left inguinal repair.Two (2) medium bard/davol perfix plug (device #1 and device #2) were implanted in the patient during this repair.On (b)(6) 2017: the patient underwent an additional surgery because the perfix plug (device #1 or device #2) failed.During the surgery the physician noted that the previously placed mesh plug "was protruding through the abdominal wall." the mesh plug was removed and another mesh device placed to repair the hernia defect.The patient has suffered and/or continues to suffer pain, discomfort, infections, intestinal blockage, hernia recurrence and the need for additional surgery.The mesh implanted in the patient failed to reasonably perform as intended.The mesh caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the mesh was initially implanted to treat.The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, and impairment.

• 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: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652659
• MDR Report Key: 8089693
• MDR Text Key: 127896792
• Report Number: 1213643-2018-04093
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: 0112760
• Device Lot Number: HUVA1651
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2011
• 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