MAUDE Adverse Event Report: COVIDIEN MESH PARIETEX 12X8 CM; MESH, SURGICAL, POLYMERIC

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

Patient Problems Discomfort (2330); Abdominal Distention (2601)

Event Date 01/20/2021

Event Type  Injury  

Event Description

On (b)(6) 2019 i had a hernia operation at (b)(6) hospital performed by dr.(b)(6).A month ago my abdomen developed a bulge at the exact site of the previous repair.It hurts and is uncomfortable.On (b)(6) 2021, i was told by another surgeon, dr.(b)(6), also at (b)(6) hospital, that it appears the previous surgery failed and i will need to have another operation to correct it.None other than the hernia mesh which is still in my lower abdomen.Take a multitude of vitamin supplements, which i have taken for many years.Fda safety report id # (b)(4).

• Brand Name: MESH PARIETEX 12X8 CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11372141
• MDR Text Key: 233516402
• Report Number: MW5099571
• 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: 02/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 75