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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SYMBOTEX HERNIA MESH; MESH, SURGICAL, POLYMERIC
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COVIDIEN SYMBOTEX HERNIA MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Health Effect - Clinical Codes Abscess (1690); Sepsis (2067)
Date of Event 07/14/2024
Type of Reportable Event Serious Injury
Event or Problem Description
I had an umbilical hernia repair done with covidien symbotex mesh on (b)(6) 2024; on (b)(6) i was admitted to the hospital with sepsis and rushed into emergency surgery which left me with an abdominal wound vac after a 13-day stay.As of (b)(6) i still have the vac as well as an abscess viewable with a computed tomography scan, albeit one decreasing in size due to the vigilance of my infectious disease and wound expert team.The mesh will remain in place unless the surgical team sees evidence that it must be removed.
 
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Brand Name
SYMBOTEX HERNIA MESH
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
MDR Report Key20397626
Report NumberMW5160758
Device Sequence Number8068872
Product Code FTL
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 10/01/2024
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? Yes
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/07/2024
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
APIXABAN.; AUGMENTIN.; GABAPENTIN.; HYDROXYZINE.; IMODIUM.; MELATONIN WOUND VAC.; METHYLPHENIDATE.; OXYCODONE.; PROPRANOLOL.; RIZATRIPTAN.
Outcome Attributed to Adverse Event Hospitalization; Disability; Life Threatening; Required Intervention;
Patient Age37 YR
Patient SexFemale
Patient Weight132 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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