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 Abscess (1690); Adhesion(s) (1695); Perforation (2001)

Event Date 04/30/2017

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol perfix plug may have caused or contributed to the reported event.The attorney alleges the patient underwent an additional surgeries for explant of device, abscess, adhesions, and a perforation.No medical records have been provided adhesions is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.A review of the manufacturing and sterilization 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.Note: not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2009:the patient underwent a left inguinal hernia repair.A bard/davol perfix plug was implanted in patient during this repair.On (b)(6) 2017: the patient experienced extreme abdominal pain presented to the emergency room.Patient was admitted that same day and underwent mesh removal surgery.The surgeon had to ¿piecemeal¿ remove the pieces of the mesh implant that had failed to incorporate and were involved with the abscess.The mesh that was incorporated and ¿going deep¿, which appeared to be ¿plugged patch¿, was left behind.The plan was to get him stabilized, get the colon cleaned up and plan for another surgery to perform a sigmoid resection to address adherence of the colon to the mesh on the inside and the resultant perforation.On (b)(6) 2017: the patient underwent the second stage of his mesh removal surgery.The surgeon performed extensive lysis of adhesions, debridement of the groin wound deep to the muscle level, a colon resection with a splenic flexure takedown and debridement of the additional portion of the mesh that was taken.The patient was hospitalized for his mesh removal surgeries beginning (b)(6) 2017 until he was discharged on (b)(6) 2017.Once patient was discharged from the hospital, he required inpatient rehabilitation for reconditioning and regaining his strength.The perfix plug implanted in patient failed to reasonably perform as intended.It had to be surgically removed, necessitating further invasive surgery to repair the very issue that the product was intended to repair, and thus providing no benefit to him.The, patient has suffered and will continue to suffer physical pain and suffering, as well as mental anguish due to the alleged defective perfix plug.

• 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: jan ling ; 100 crossings blvd.; warwick, RI 02886 ; 8015652663
• MDR Report Key: 8075091
• MDR Text Key: 127285299
• Report Number: 1213643-2018-04050
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Catalogue Number: 0112970
• Device Lot Number: HUSI2139
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2008
• 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): Hospitalization; Required Intervention; Disability