MAUDE Adverse Event Report: SOFRADIM PRODUCTION HERNIA MESH PROGRIP; MESH, SURGICAL, POLYMERIC

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

I had hernia surgery and am in constant pain with a burning feeling and what feels like something coarse rubbing my belly button wall.I am constantly in pain and have to brace my self with every step i take to not feel pain.I had the surgery on (b)(6) 2022 and i thought the pain would get better day by day but it almost feels just like i had surgery yesterday.

• Brand Name: HERNIA MESH PROGRIP
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION
• MDR Report Key: 16411456
• MDR Text Key: 310045986
• Report Number: MW5115071
• Device Sequence Number: 1
• 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: Patient
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2023
• Patient Sequence Number: 1
• Treatment: ESOMEPRAZOLE.; ORAL MEDICAL MARIJUANA.
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White