MAUDE Adverse Event Report: ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH

Model Number PHY1520R

Device Problem Nonstandard Device (1420)

Patient Problem Hernia (2240)

Event Date 04/01/2013

Event Type  malfunction  

Event Description

Original hernia repair conducted with product that has now voluntarily been recalled by the mfr due to greater than expected recurrence/operative rates.Pt required a second procedure due to recurrent hernia.

• Brand Name: PHYSIOMESH FLEXIBLE COMPOSITE MESH
• Type of Device: MESH
• Manufacturer (Section D): ETHICON; somerville NJ 08876
• MDR Report Key: 5754465
• MDR Text Key: 48444813
• Report Number: MW5063063
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2014
• Device Model Number: PHY1520R
• Device Lot Number: EECKJAO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 80