MAUDE Adverse Event Report: ETHICON 2-0 VICRYL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Hernia (2240)

Event Date 01/02/2017

Event Type  Injury  

Event Description

On (b)(6) 2014 had surgery for a left inguinal hernia where mesh and a mesh plug were sued.Experienced pain from approx (b)(6) 2016 until diagnosed with repeated hernia associated with mesh not doing as needed to control hernia.On (b)(6) 2017, diagnosed with same hernia and concerns with previous mesh surgery.

• Brand Name: 2-0 VICRYL
• Type of Device: 2-0 VICRYL
• Manufacturer (Section D): ETHICON
• MDR Report Key: 6300446
• MDR Text Key: 66595221
• Report Number: MW5067648
• 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: Patient
• Type of Report: Initial
• Report Date: 02/01/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; FISH OIL; GEMFIBROZIL; HYDROCHLOROTHIAZIDE; OMEPRAZOL; SERTRALINE; VITAMIN D; VITAMIN E
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 93