MAUDE Adverse Event Report: BARD MESH

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Anemia (1706); Bacterial Infection (1735); Pain (1994); Arthralgia (2355); Confusion/ Disorientation (2553)

Event Date 03/11/2016

Event Type  Injury  

Event Description

Mesh placement, 3 months later mesh migration and another hernia new mesh, bowel entanglement, bigger mesh on top of the other, 6 month staph infection coming out of umbilicus, pain, pain, exploratory, cleaned out infection, removed mesh, new hernia with bowel obstruction and mesh placed.All the pain is back, the brain fog, the aching joints my anemia is back.Doctors are killing me.

• Brand Name: MESH
• Type of Device: MESH
• Manufacturer (Section D): BARD
• MDR Report Key: 7104460
• MDR Text Key: 94535236
• Report Number: MW5073876
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 42 YR
• Patient Weight: 86