MAUDE Adverse Event Report: ATRIUM HERNIA MESH MESH, SURGICAL, POLYMERIC

Device Problem Sticking (1597)

Patient Problems Abdominal Pain (1685); Hernia (2240)

Event Date 03/08/2016

Event Type  Injury  

Event Description

I had umbilical. Hernia repair at (b)(6) hospital, (b)(6) by dr. (b)(6) on (b)(6) 2016. The hernia was repaired with a atrium mesh, according to hospital records. After the repair, i was diagnosed with prostate cancer in (b)(6) 2016. I scheduled a radical prostatectomy for (b)(6) 2016 at (b)(6) hospital, (b)(6). The surgeon was dr. (b)(6). The procedure was robotic. According to dr. (b)(6) after the surgery, he told my wife that he almost was not able to conduct the surgery because my small intestine was attached to the atrium mesh. He did finally detach the two, and completed the surgery. Ten days after the surgery, i had a follow up appointment with dr. (b)(6). At the follow up, i was experiencing severe pain in my abdomen. Dr. (b)(6) admitted me to (b)(6) hospital, and brought a gastroenterologist onboard to assist with my treatment. My gut was inflamed, therefore it was restricted at the site that the small intestine and the atrium mesh was connected. I stayed in the hospital 4 days waiting on my gut to calm down, which it did. I have since had another painful episode that did not require a hospital stay, only because i used some learning from the prior episode to "get some relief". The site is still tender to touch, and it feels like a mass in over my navel. I do not know what to do about this, if anything. I also had my gallbladder removed in (b)(6) 2017 at (b)(6) medical center. The surgeon was dr. (b)(6). He checked around the umbilical area, and said that he found on small area adhesion, and repaired it.

• Brand Name: HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM
• MDR Report Key: 7330355
• MDR Text Key: 102218066
• Report Number: MW5075787
• 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: Patient
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

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?

Type of Device Usage

Patient Treatment Data

Date Received: 03/08/2018 Patient Sequence Number: 1