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U.S. Department of Health and Human Services

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

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ASPIDE MEDICAL SURGIMESH XB MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Seizures (2063); Urticaria (2278); Numbness (2415); Ambulation Difficulties (2544)
Event Date 09/23/2017
Event Type  Injury  
Event Description

I had hernia repair with mesh was done on (b)(6) 2017. On (b)(6) 2017, while out of town to visit my son, i began having hives and my face began to swell. I went to the er in the town my son lives where they treated me with epinephrine, benadryl and a steroid. Forty five minutes after i returned home, the following morning, it happened again. So i went to our local hospital where they gave me epinephrine, benadryl and steroids. I ended back at the emergency room several hours later where the routine was repeated. I promised to follow up with my regular dr in the morning. When he saw me, he immediately admitted me to the hospital. Shortly after, i went into anaphylaxis. My dr sent me to a larger hospital to have the mesh removed. The dr at the other hospital didn't think it was the mesh and after 24 hours of icu, he had me transported to another hospital. I called the surgeon that had implanted the mesh, hoping he would agree to remove it. He said he didn't think it was the mesh either. I spent 12 days in icu at (b)(6) medical center in (b)(6) where testing for every possible condition was done on me before they finally decided to remove the mesh on (b)(6) 2017. Own repair of right hernia was on (b)(6) 2018. A hysterectomy was done on (b)(6) 2018 in hopes of reducing pain. I am still in quite a lot of pain over a year after the incident. If i stand or walk for more than 30 minutes, my toes go numb and now i have started having seizures (2 in the last week).

 
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Brand NameSURGIMESH XB
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ASPIDE MEDICAL
MDR Report Key8074680
MDR Text Key127550514
Report NumberMW5081312
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 11/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device EXPIRATION Date07/31/2013
Was Device Available For Evaluation? No
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: 11/14/2018 Patient Sequence Number: 1
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