MAUDE Adverse Event Report: ETHICON ULTRA PRO; MESH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Disability (2371)

Event Date 07/08/2013

Event Type  Injury  

Event Description

I have mesh implants in four areas; major pain and unable to function on a regular basis.I was treated for chronic pain - how easy that was.(b)(6) clinic will not give me the implant log info for hernia repair.Now, do you want details of five years of being ignored to the point my organs are affected; my right leg has started to cause problems and i can't get help.You contact me.

• Brand Name: ULTRA PRO
• Type of Device: MESH
• Manufacturer (Section D): ETHICON
• MDR Report Key: 5335360
• MDR Text Key: 34762532
• Report Number: MW5058792
• 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
• Report Date: 12/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 57