MAUDE Adverse Event Report: ETHICON LLC PROLENE SUTURE; MESH, SURGICAL, POLYMERIC

Model Number 8706

Device Problem Break (1069)

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

Event Date 08/07/2020

Event Type  malfunction  

Event Description

Multiple 6-0 prolene sutures with common lot number noted to be breaking along varying areas of the suture throughout the case.Fda safety report id #: (b)(4).

• Brand Name: PROLENE SUTURE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON LLC; somerville NJ
• MDR Report Key: 10390350
• MDR Text Key: 202614247
• Report Number: MW5095991
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 8706
• Device Catalogue Number: 8706
• Device Lot Number: PDH189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR