MAUDE Adverse Event Report: SURGICAL MESH; MESH, SURGICAL, POLYMERIC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Nausea (1970); Pain (1994)

Event Date 03/19/2020

Event Type  Injury  

Event Description

Chronic pain and nausea.Unable to lift, bend, or sit up straight.Ct scan showed issue.Fda safety report id # (b)(4).

• Brand Name: SURGICAL MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• MDR Report Key: 15079513
• MDR Text Key: 296419213
• Report Number: MW5111044
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: AMBIEN CR; LAMICTAL; LISINOPRIL; PANTOPRAZOLE; SEROQUEL; VITAMINS C, B12, D3, CALMAG, OMEGA 3
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White