MAUDE Adverse Event Report:; MESH

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Pain (1994); Inadequate Pain Relief (2388); Foreign Body In Patient (2687)

Event Date 10/30/2013

Event Type  Injury  

Event Description

Pt had a surgery for lf kidney cancer on (b)(6) 2015 by (b)(6).Mesh and clips were also implanted.Patient had pain, bulge on left side of abdomen.On (b)(6) 2015, patient went to dr.(b)(6) for copd.Pt had chest x-ray and the dr saw mesh and clips on the x-ray, also the kidney is in lying position instead of upright position.The condition was confirmed with the ct scan.Everything was pulled to the suture and it was very painful.Patient is on pain medication, hydrocodone, 5 mg when necessary.Current patient is diagnosed with posterior abdominal wall hernia, renal cell carinoma, hypertension, flank pain and risk for intestinal twisting.Patient feels awful and has to lay down.Patient will have second surgery on (b)(6) 2015 with (b)(6).Patient will call back with the device info from the hosp.

Event Description

Additional information received from reporter on 07/31/2015 for mw5042930.On (b)(6), 2013, ct scan shows ok.On (b)(6), 2015, kidney tumor removed (left).X ray revealed collapse of prosthetic clips etc.New surgery required- urology (b)(6).Request for records from (b)(6) med.Center.They denied any mesh clips were used (lied).On (b)(6), 2015, dr.(b)(6) did xray, clips visible kidney and stomach lying on left side stamped urgent and priority.Kidney/mesh collapsed.Do you want surgeon to keep prosthetics used (b)(6), 2011 as evidence or will report from (b)(6) be enough evidence? used implants clips etc.On (b)(6), 2011, (b)(6) med.Center.New surgery required for kidney cancer, disabled.Contact (b)(6) med.Center (b)(6) did surgery.I am disabled on ssi.I have contacted social security, also a lawyer as of intent to sue- lawsuit.Dangerous unnecessary second surgery required (b)(6), 2015.

• Brand Name: UNK
• Type of Device: MESH
• MDR Report Key: 4815076
• MDR Text Key: 21769431
• Report Number: MW5042930
• 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: 05/29/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 82