MAUDE Adverse Event Report: BARD-DAVOL PERFIX PLUG LARGE

Model Number 0112770

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Necrosis (1971); Nerve Damage (1979); Pain (1994); Scarring (2061); Sepsis (2067); Vomiting (2144); Numbness (2415); Weight Changes (2607)

Event Date 07/06/2010

Event Type  Injury  

Event Description

On (b)(6) 2010, i was involuntarily implanted with a bard perfix plug and patch, the reference # is (b)(4) and the lot # huti1991.Within days, it was clear that my body was having an adverse reaction and within a week, it was severely infected and bleeding and draining pus.My scrotum became 4" and then eventually 7".The wound did not heal for more than one month.No drain or wound vac was put in.The wound was allowed to close from the outside in.Within months, the infection went systematically into my blood stream and caused sepsis once or twice.I have been hospitalized inpatient and outpatient and treated by infectious disease specialists.They were not able to rid my body of the infection to this date.It causes painful flesh eating pustules and boils which hurt very much and are embarrassing and contagious.My wife now has the infection.There is nerve damage and pain, scarring and adhesions, it has constricted my vas and my spermatic cord and i have been offered several radical surgery procedures all of which are explained as high risk.I would lose a large portion of my groin muscle and tissue and require more mesh and more surgery.It is likely that i will lose my testicle.I would also lose all sensation to my groin and parts of my lower body.I have 3 major pain centers that debilitate me and have kept me from working for 5 years: skin and nerve pain from right knee to right nipple like burning and pin pricking also with spasms; pain deep inside my gut and stomach centered around the surgical site like wrenching, twisting, tearing pain which makes me fall on ground; testicle/sperm pain like a constant feeling of a ten pound weight on my testes or being compressed hard my hand and some days it will go sharply intense like i have been kicked in the testes and i will become nauseous for hours and vomit.Lastly worth noting is my decreased libido from sexual pain and marriage difficulty.Also, should be noted that i have lost over 30 pounds and cannot eat even a small or medium portion of food without vomiting.Also, i have disgusting night sweats every night and my bed and sheets are disgusting you can wring them out.

• Brand Name: PERFIX PLUG LARGE
• Type of Device: PERFIX PLUG LARGE
• Manufacturer (Section D): BARD-DAVOL
• MDR Report Key: 6449194
• MDR Text Key: 71377254
• Report Number: MW5068783
• 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: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 0112770
• Device Catalogue Number: 0112770
• Device Lot Number: HUTI1991
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CYCLOBENZAPRINE; HIBICLENS SOAP; OMEPRAZOLE; OTC MEDS: MULTI-VITAMIN; RX MEDS: TRAMADOL
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 28 YR
• Patient Weight: 75