MAUDE Adverse Event Report: C.R. BARD, INC. SURGICAL MESH; MESH, SURGICAL, POLYMERIC

Model Number HUCY1401 LEFT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Pain (1994); Post Operative Wound Infection (2446); Syncope/Fainting (4411); Skin Inflammation/ Irritation (4545)

Event Date 08/20/2019

Event Type  Injury  

Event Description

Caller stated that he was implanted with a mesh on (b)(6) 2019.One on the right side of the groin and another on the left side.Pt stated after implantation he started to experience pain in the groin area.Pt met with his doctor to discuss his symptoms, while he was at the doctor's office he fainted.He was later revived.Patient stated when he got home after meeting with his doctor he noticed that his body is inflamed and red.His son took him to the emergency room where he was admitted to the hospital.He was in the hospital for two weeks because he develop gangrene and his wound was infected.He was placed on antibiotics.He continued to received treatment until his wound is cleared from infection and healed.On (b)(6) 2021 the mesh was explanted.

• Brand Name: SURGICAL MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 12954591
• MDR Text Key: 281937358
• Report Number: MW5105877
• Device Sequence Number: 2
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: HUCY1401 LEFT
• Device Catalogue Number: REF 0112970
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Hispanic
• Patient Race: White