MAUDE Adverse Event Report: C. R. BARD, INC. MARLEX MESH; MESH, SURGICAL POLYMERIC

Device Problem Protective Measures Problem (3015)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/13/2018

Event Type  Injury  

Event Description

Mom had a hernia surgery and the mesh became ¿undone¿ so an additional surgery was needed.I do not have the correct dates of these surgeries.Recently in (b)(6) 2018, mom had an ileus of the small intestines in which the surgeon thought the small intestine attached to the mesh.One brand name of the mesh was marlex and the other was teflon.Surgeries and stays in assistant living / skill care for a month after staying in hosp for two months.Surgical mesh for hernias.

• Brand Name: MARLEX MESH
• Type of Device: MESH, SURGICAL POLYMERIC
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 7947040
• MDR Text Key: 123494161
• Report Number: MW5080420
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 10/05/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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; Other
• Patient Age: 87 YR
• Patient Weight: 63