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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR SYMBOTEX MEDTRONIC INC

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MEDTRONIC SOFAMOR SYMBOTEX MEDTRONIC INC Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Vomiting (2144); Obstruction/Occlusion (2422)
Event Type  Injury  
Event Description

Surgery; in (b)(6) 2018, i had surgery to correct an incisional hernia that was the result of a davinci robotic gallbladder removal surgery in (b)(6) 2016. I was informed that hernia mesh would be used to repair the hernia, and this was the only option i was given. My doctor used symbotex by medtronic mesh and the hernia was repaired. From that time, i had recurrent stomach pain that i lived with and in (b)(6) 2020 i suffered a serious stomach episode at home which included severe pain with nausea and vomiting and diarrhea that last throughout the entire night, but i treated at home. In (b)(6) 2020, i again had the same type of episode but on this occasion, i went to the emergency room and was treated for a small bowel obstruction with ng tube and admission into the hospital for treatment. I had surgery in (b)(6) 2020 and found that my small bowel was twisted 180 degrees and adhered to my mesh. The surgeon cut my bowel away from my mesh, leaving mesh adhered to my bowel for fear of damaging the bowel itself and i was admitted to the hospital for what was supposed to be a day surgery due to the fact that i got a fever and had uncontrolled pain and low blood pressure. The issue with my mesh has caused me to miss multiple days from my job and pain/suffering as well as numerous medical expenses. Fda safety report id # (b)(4).

 
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Brand NameSYMBOTEX
Type of DeviceMEDTRONIC INC
Manufacturer (Section D)
MEDTRONIC SOFAMOR
MDR Report Key11170195
MDR Text Key227177376
Report NumberMW5098824
Device Sequence Number1
Product Code FTL
Combination Product (Y/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 01/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
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: 01/13/2021 Patient Sequence Number: 1
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