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

Catalog Number 0112770

Device Problems Entrapment of Device (1212); Defective Device (2588)

Patient Problems Inflammation (1932); Hernia (2240); Disability (2371)

Event Date 09/19/2014

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol perfix plug device may have caused or contributed to the reported event.To date no medical records have been provided.The attorney alleges the patient underwent an additional surgery for recurrent hernia and partial removal of the device.The mesh was unwrapped from the spermatic cord and removed in a piecemeal fashion; however, no sample has been returned for evaluation.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.A review of the manufacturing 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: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2013: the patient underwent left inguinal hernia repair.A bard/davol perfix plug was implanted in the patient during this repair.On (b)(6) 2014: the patient underwent surgery for treatment of groin pain, a recurrent hernia and partial mesh.Upon entering the patient's abdomen, the surgeon observed that "where the mesh was wrapped around the spermatic cord, it was fairly scarred in." as a result, the mesh was unwrapped from the spermatic cord and removed in a piecemeal fashion.Patient suffered and continues to suffer from severe pain, diarrhea, chills, hot and cold flashes, inflammation, loss of appetite and discomfort, which affect his everyday life.Patient also requires ongoing physical care and treatment.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: 7903915
• MDR Text Key: 121563432
• Report Number: 1213643-2018-03258
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615
• 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: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Catalogue Number: 0112770
• Device Lot Number: HUXD2366
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2013
• 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