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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH MESH, SURGICAL, POLYMERIC

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ASPIDE MEDICAL SURGIMESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Fever (1858); Pain (1994)
Event Date 09/10/2017
Event Type  Injury  
Event Description
Pt stated that roughly 4 weeks after the initial surgery, he started having pain and lump reappearance, and only had comfort when laying down, while standing up and walking meant excruciating pain. Pt had two f/u appts to address the symptoms. During the first f/u appt, pt states that he was sitting for 45 mins waiting for the dr and therefore, the lump and pain symptoms were not apparent for the dr. The dr arrived and did a quick palpation of the area and told the pt he was fine. The pt came back for a second f/u but instead during this time chose to wait for the dr standing in order to show the dr that his symptoms were true. By the time, the dr appeared, the pt was bunched in pain and the dr did an examination to determine that the mesh wasn't functioning as intended. The dr recommended physical therapy as a result and the pt completed it but it only resulted in more pain. The pt also notes that he is not overweight, takes care of himself, does not smoke, walks everyday, and is healthy for his age. The pt also delineated that the initial surgery was laparoscopic and the revision surgery ((b)(6) 2017) was performed via incision. During the revision surgery, the surgeon did not remove the faulty mesh but instead put another mesh on top of it. After the revision, the pt began experiencing body aches and had a fever with a temperature of 104. The drs were only able to diagnose a fever for the pt and were not able to link it to the mesh. Since then, the pt has had daily pain and feels pain doing everyday activities such as work around the house, walking, and pain during intercourse two years later.
 
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Brand NameSURGIMESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ASPIDE MEDICAL
MDR Report Key8749159
MDR Text Key149807974
Report NumberMW5087705
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 06/28/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 06/28/2019 Patient Sequence Number: 1
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