MAUDE Adverse Event Report: CR BARD KEYHOLE MESH SURGICAL MESH

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 04/21/2016

Event Type  Injury  

Event Description

I had an inguinal hernia repaired with a bard keyhole surgical mesh at (b)(6) hospital.It was supposed to be an outpatient surgery.Due to pain, i was hospitalized for three days after the surgery.I have had continuing pain since the surgery at the surgical site and in my groin area.I have had three nerve block injections into the ilioinguinal nerve with minimal pain relief.It is a year later, and i take daily pain medication to lessen the pain from the surgery.The pain is so bad that i have trouble doing regular daily activities.I have reduced my work to part-time because of the pain.

• Brand Name: SURGICAL MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): CR BARD KEYHOLE MESH
• MDR Report Key: 6559929
• MDR Text Key: 75034475
• Report Number: MW5069698
• Device Sequence Number: 1
• Product Code: FTM
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FINASTERIDE; LISINOPRIL; OTC MEDS: NA; PANTOPRAZOLE; RX MEDS: AMITRIPTYLINE; TERAZOSIN
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 57 YR
• Patient Weight: 106