MAUDE Adverse Event Report: TYCO HEALTHCARE/COVIDIEN PARIETEX COMPOSITE

Model Number PCO2015

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Necrosis (1971); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Had to have a penniculectomy because fat necrosis had grown onto mesh and was hurting.I've been hospitalized and had two hernia repairs since then, both times i had additional mesh installed, on (b)(6) 2014 and (b)(6) 2016.

• Brand Name: PARIETEX COMPOSITE
• Type of Device: PARIETEX COMPOSITE
• Manufacturer (Section D): TYCO HEALTHCARE/COVIDIEN
• MDR Report Key: 6489443
• MDR Text Key: 72806478
• Report Number: MW5069071
• 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
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/01/2015
• Device Model Number: PCO2015
• Device Lot Number: PKJ00661
• 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 Weight: 91