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U.S. Department of Health and Human Services


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Model Number SLF-FX 10X15CM RT
Device Problem Unintended Movement (3026)
Patient Problems Pain (1994); Burning Sensation (2146); Discomfort (2330)
Event Date 02/19/2018
Event Type  Injury  
Event Description
On (b)(6) , i had a progrip mesh used on my inguinal right hernia. When i woke up i was in a lot of pain. I asked for pain medication and was told that was normal. After 2 weeks, i was still in a lot of pain. It felt like there was a stabbing pain on my right side. I also could not stand up straight at all. I felt like something on my inside was ripping, it also felt like someone was taking a knife and stabbing my stomach. Lastly, i felt like someone had taken a hot pain and had burned my stomach. I also had my belly button repaired. My belly button always felt like there was razor blade in my stomach. When i press anything on it, it is so painful. It is even painful to have my underwear on my stomach. I have to wear my underwear really low. After numerous marcaine shots i was still in pain. I also had 2 nerve blocks done. At about 8 weeks i was finally to walk upright, but all three places still hurt a lot. I had weeks of physical therapy as well as months of acupuncture and am still in pain. I have developed a lump under my belly where the inguinal hernia mesh is. That is exactly where it hurts the most, my belly button still feels like there is a razor blade inside. It was such a stabbing pain that i thought for sure the dr must have left something inside of me. I had an ultrasound and a ct scan with contrast done. Both did not show anything. I am in a lot of pain. I know it is the mesh that is stabbing into me. Sometimes it feels like the mesh moves over different nerves and i get stabbing pains in my vagina. The pains in vagina can last hours, until i got to sleep and lay flat. I cannot lay on my sides anymore because it feels like the mesh is pulling the inside of my skin like a weight and it hurts a lot. I cant sleep well at night because it hurts and wakes me up through out the night. My dr put me on gabapentin as well as tylenol and something else. I can't remember what it was, but it didn't help at all. This was performed using a robot.
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Manufacturer (Section D)
MDR Report Key7885057
MDR Text Key120708113
Report NumberMW5079847
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSLF-FX 10X15CM RT
Device Lot NumberPRJ0768X
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: 09/17/2018 Patient Sequence Number: 1