MAUDE Adverse Event Report: COVIDIEN PARIETEX PROGRIP; MESH, SURGICAL, POLYMERIC

Catalog Number TEM1208GL

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

Patient Problems Diarrhea (1811); Headache (1880); Nausea (1970); Pain (1994); Anxiety (2328); Arthralgia (2355); Depression (2361); Constipation (3274)

Event Date 05/18/2014

Event Type  Injury  

Event Description

Pain in my left groin in leg, headaches, anxiety, joint aches and nausea, pain with sex, constipation/diarrhea, and depression.

• Brand Name: PARIETEX PROGRIP
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8499892
• MDR Text Key: 141521366
• Report Number: MW5085712
• Device Sequence Number: 0
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: TEM1208GL
• Device Lot Number: SMI100312
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ATAZANAVIR 300MG DAILY; ONDANSETRON 4MG AS NEEDED; RITONAVIR 100MG DAILY; TRUVADA - 200/300MG DAILY
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Weight: 64