MAUDE Adverse Event Report: JOHNSON AND JOHNSON MESH IMPLANT; SURGICAL MESH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Internal Organ Perforation (1987); Pain (1994); Hernia (2240); Inadequate Pain Relief (2388); Prolapse (2475)

Event Date 03/13/2017

Event Type  Injury  

Event Description

Had mesh put in and the pain got worse after it was put in.Had it removed in 2012.Just to have mesh put back in after i was left with a hole in my lower stomach.My small intestine was falling through.So i ended up with 7 hernias a hole and they had to go back in three more times to fix the mesh.I still can't hold my grandchildren because of my stomach pain.I live on pain pills that don't help.

• Brand Name: MESH IMPLANT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): JOHNSON AND JOHNSON
• MDR Report Key: 6439126
• MDR Text Key: 71162888
• Report Number: MW5068696
• 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: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Treatment: AMITRIPTYLINE; HYDROCHLORIDE; HYDROCODONE. ; METOPROLOL; ONDANSETRON HCL; RX MEDS: GABAPENTIN
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 88