MAUDE Adverse Event Report: JOHNSON & JOHNSON / ETHICON, INC. ULTRAPRO HERNIA MESH SYSTEM; MESH, SURGICAL, POLYMERIC

Device Problem Material Perforation (2205)

Patient Problems Adhesion(s) (1695); No Code Available (3191)

Event Date 11/22/2019

Event Type  Injury  

Event Description

Had ethicon ultrapro hernia mesh system implanted in 2015.In 2019, while having prostate surgery, small intestine adhesion to mesh also had a perforation.Had 4 inches of the affected intestine removed.Pathology report indicated mesh granules in the sample.Fda safety report id# (b)(4).

• Brand Name: ULTRAPRO HERNIA MESH SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): JOHNSON & JOHNSON / ETHICON, INC.
• MDR Report Key: 9805171
• MDR Text Key: 182893450
• Report Number: MW5093608
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 79