MAUDE Adverse Event Report: COVIDIEN PROGRIP MESH; MESH, SURGICAL, POLYMERIC

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.

• Brand Name: PROGRIP MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 7885057
• MDR Text Key: 120708113
• Report Number: MW5079847
• 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: 09/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SLF-FX 10X15CM RT
• Device Lot Number: PRJ0768X
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 41 YR
• Patient Weight: 71