MAUDE Adverse Event Report: PARIETEX MESH 20 X 30 CM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Complaint, Ill-Defined (2331)

Event Date 12/01/2012

Event Type  Other  

Event Description

Lots of complications ever since mesh was implanted.In and out of doctors offices.Have to wear a binder.Have several adhesions.Doctors will not take mesh out due to the risk of infections.

• Brand Name: PARIETEX MESH 20 X 30 CM
• Type of Device: MESH
• MDR Report Key: 5137889
• MDR Text Key: 28076064
• Report Number: MW5056907
• 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
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1