MAUDE Adverse Event Report: PROLENE MESH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Date 04/29/2017

Event Type  Injury  

Event Description

I had hernia mesh put inside in 2011, was never told of possible infection or that it could shrink in fact i was told this would not come undone, it was a very large piece of prolene mesh i suffered for years not knowing there was a serious infection happening that could not be detected! how many lives have to be destroyed before plastic is no longer placed in human beings!.

• Brand Name: PROLENE MESH
• Type of Device: MESH
• MDR Report Key: 6975867
• MDR Text Key: 90334123
• Report Number: MW5072944
• 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: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 55 YR
• Patient Weight: 59