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

Catalog Number 0112770

Device Problems Material Erosion (1214); Defective Device (2588); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Disability (2371); Bowel Perforation (2668)

Event Date 10/13/2013

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney alleged that the patient had undergone surgical intervention due to hernia recurrence, mesh erosion into the small bowel, infection and was injured permanently and severely; however, no details have been provided.A review of the ifu finds it to be adequate.The fmea review identifies multiple potential adverse patient outcomes associated with surgery/use of the device including mesh erosion, bowel perforation, infection and recurrence.The review identifies controls in place to assess the failure modes and potential harms.Information provided by the patient's attorney is limited and review of the ifu and fmea does not assist in the identification of the root cause of the patient's alleged post-op complications.No manufacturing issues associated to the reported event were found in the reviewed lot.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that the patient underwent surgery for umbilical hernia with bard/davol perfix plug on or about (b)(6) 2001.As reported, the patient is making a claim for an adverse patient outcome against the perfix plug.On or about (b)(6) 2013, the patient underwent a surgery to again repair the umbilical hernia and remove the perfix plug due to mesh erosion into the plaintiff's small bowel and infection.It is alleged that the patient was injured permanently and severely.It is also alleged that the patient has suffered and will continue to suffer physical pain, mental anguish, chronic pain, as well as psychological stress and depression.

• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 9687315
• MDR Text Key: 178382976
• Report Number: 1213643-2020-01091
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2004
• Device Catalogue Number: 0112770
• Device Lot Number: 43KJD210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/1999
• 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): Life Threatening; Required Intervention; Disability