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

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).

• Brand Name: SURGIMESH XB
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASPIDE MEDICAL
• MDR Report Key: 8074680
• MDR Text Key: 127550514
• Report Number: MW5081312
• 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: 11/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 42 YR
• Patient Weight: 84