MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ETHICON ETHICON PROLENE MESH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Failure to Anastomose (1028); Purulent Discharge (1812)

Event Date 12/20/2013

Event Type  Injury  

Event Description

Ethicon prolene mesh was used on ventral hernias.Shortly after the surgery the suture line opened up and put out pus.It finally closed 14 months later.Since then about every 6 months another area opens up and puts out pus.In (b)(6) 2016, i underwent 12 operations to drain the fluid off my abdomen.In all 6000 ml were drained off.All holes closed up until the end of(b)(6) 2017.Then the pus came out of the holes.I have been hospitalized now 4 times since (b)(6) 2016.

• Brand Name: ETHICON PROLENE MESH
• Type of Device: ETHICON PROLENE MESH
• Manufacturer (Section D): JOHNSON AND JOHNSON/ETHICON
• MDR Report Key: 6721532
• MDR Text Key: 80464866
• Report Number: MW5071065
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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; Disability
• Patient Age: 66 YR
• Patient Weight: 70