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

Catalog Number 0112780

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

Patient Problems Neuropathy (1983); Hernia (2240); Disability (2371)

Event Date 10/31/2016

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 cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.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) 2015: the patient was implanted with a bard/davol perfix plug for the repair of a left inguinal hernia.No less than a year had passed before the patient started experiencing pain radiating from his abdomen and neuropathy.The patient's physicians elected for a repair of surgery of the hernia and hernia mesh.On (b)(6) 2016- the patient underwent surgery.Upon entering the abdominal cavity, the patient's surgeon noted that the bard perfix plug had failed and removed part of the mesh.It is alleged that as a direct and proximate result of davol's and bard's negligence, the patient has experienced significant physical injury, physical pain and suffering, permanent injury, and has undergone medical treatment and will likely undergo further medical treatment and procedures due to the alleged defective mesh.The patient's mesh failed while in his body causing the patient to develop serious physical complications which required subsequent, painful and unnecessary repair surgery.

• 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: 8191556
• MDR Text Key: 131220776
• Report Number: 1213643-2018-04948
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0112780
• Device Lot Number: HUZD1626
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2018
• 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