MAUDE Adverse Event Report: BARD DAVOL PERFIX PLUG (MONOFILAMENT KNITTED POLYPROPYLENE); BARD MESH PERFIX PLUG (EXTRA LARGE PLUG)

Catalog Number 0112780

Device Problems Material Discolored (1170); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problems Abdominal Pain (1685); Abrasion (1689); Fatigue (1849); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Rash (2033); Skin Irritation (2076); Tissue Damage (2104); Urinary Tract Infection (2120); Discomfort (2330); Depression (2361)

Event Date 03/02/2001

Event Type  Injury  

Event Description

Reporter stated that he has been a healthy individual up until this process was done.He stated that on (b)(6) 2001 he went in for inguinal hernia repair and varicocele repair, both on the left side.After that procedure, he started off having uti's, bladder infection, kidney infections.He was diagnosed with interstitial cystitis on (b)(6) 2002.He further experienced blood in stool, mucus in stool, severe stomach pains and was diagnosed with ulcerative colitis on (b)(6) 2005.He was placed on numerous medications for these conditions.He suffered from fibromyalgia, chronic fatigue, chronic prostatitis, pain, discomfort, rectal blood loss,unexplained urinary blood loss, polycythemia vera.With all of these symptoms, he required routine phlebotomy to remove blood and decrease the number of rbcs.Colonoscopies were done every two years.He further presented with rash, skin irritation, and was also treated for depression.Deep stick urine analysis done at doctor's office was positive but when sent out for culture, results sometimes came back negative.He had painful bladder syndrome, chronic pelvic pain syndrome,pelvic floor dysfunction, chronic overall inflammation.During explantation of the device the patch was fused to the plug and formed a meshoma.There was abrasion of the vas deferens of the left side and the mesh was wrapped around the spermatic cord.The vas deferens was encased in the groove of the mesh.The mesh was entangled with the femoral nerve and femoral artery.This affected the ileo-inguinal nerve and genito-femoral nerve.When the mesh was removed, it was hardened, jagged, deteriorating, black,bloody and curled.Doctor said it caused foreign body reaction and autoimmune responses, nerve and tissue damage and restricted flow to the area.Reporter stated that some of these symptoms have resolved after the device explant.

• Brand Name: PERFIX PLUG (MONOFILAMENT KNITTED POLYPROPYLENE)
• Type of Device: BARD MESH PERFIX PLUG (EXTRA LARGE PLUG)
• Manufacturer (Section D): BARD DAVOL
• MDR Report Key: 5875101
• MDR Text Key: 52230078
• Report Number: MW5064044
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 0112780
• Device Lot Number: 431KD077
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 22 YR
• Patient Weight: 102