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

Catalog Number 0112760

Device Problems Material Rupture (1546); Defective Device (2588); Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Hernia (2240); Deformity/ Disfigurement (2360); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

The patient reports that he is currently awaiting approval to undergo a repair surgery.The patient was asked to follow up with davol following his surgery.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Recurrence is identified in the adverse reaction section of the ifu as a possible complication.Based on the information available at this time, no conclusions can be made.If additional information is obtained, this report will be updated.Device remains implanted.

Event Description

The following was reported to davol: the patient reports that on (b)(6) 2016 he underwent a left inguinal, non reducible hernia repair with the implant of a bard perfix plug.Following this repair, the patient reports that he began to experience pain and pressure in the groin; however, attributed this to be postoperative in nature.The patient reports the symptoms continued along with some occasional burning and itching as well as warmth to touch.In (b)(6) 2016, the patient underwent a physical assessment by a general practitioner and was then referred for a surgeon consult in which another physical exam was performed.The patient reports the surgeon felt a bulge at the bottom of the mesh and indicates the mesh has "ruptured.".

Manufacturer Narrative

Addendum to previous information.This supplemental emdr is being sent to document additional information provided by the patient's attorney.Additional allegations of disability, nerve pain and disfigurement are noted.No medical records have been provided.Based on the information available at this time no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.

Event Description

As reported on 11/14/2016: the following was reported to davol : the patient reports that on (b)(6) 2016 he underwent a left inguinal, non reducible hernia repair with the implant of a bard perfix plug.Following this repair the patient reports that he began to experience pain and pressure in the groin; however, attributed this to be postoperative in nature.The patient reports the symptoms continued along with some occasional burning and itching as well as warmth to touch.In (b)(6) 2016 the patient underwent a physical assessment by a general practitioner and was then referred for a surgeon consult in which another physical exam was performed.The patient reports the surgeon felt a bulge at the bottom of the mesh and indicates the mesh has "ruptured." addendum per legal complaint: the following was alleged by the patient's attorney: the patient continues to suffer pain and permanent disfigurement and to include but not limited to the following: bowel protrusion and partial obstruction, nerve trapped in mesh, erectile dysfunction/numbness at base of penis and scrotum, tingling/numbness feeling in front part of upper thigh, pulling from scrotum to groin area, constant pressure feeling in groin area, severe spiking pain, problems with gait, incontinence and unable to defecate for days at a time (usually 4-5 days).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
• MDR Report Key: 6100227
• MDR Text Key: 59798456
• Report Number: 1213643-2016-00518
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 0112760
• Device Lot Number: HUZJ0318
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability