MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH 4.3 CM X 4.3 CMT MESH SURGICAL POLYMERIC

Lot Number LK8CHHB0

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2019

Event Type  malfunction  

Event Description

During hernia surgery, mesh to be placed fell apart in places. All parts were able to be retrieved.

• Brand Name: PROCEED VENTRAL PATCH 4.3 CM X 4.3 CMT
• Type of Device: MESH SURGICAL POLYMERIC
• Manufacturer (Section D): ETHICON INC.
• MDR Report Key: 8560492
• MDR Text Key: 143541310
• Report Number: MW5086229
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2019
• Device Lot Number: LK8CHHB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage