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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC / SOFRADIM PRODUCTION SYMBOTEX MESH; MESH, SURGICAL, POLYMERIC

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MEDTRONIC / SOFRADIM PRODUCTION SYMBOTEX MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Failure of Implant (1924); Pain (1994); Hernia (2240); Paresthesia (4421)
Event Date 07/20/2022
Event Type  Injury  
Event Description
Indwelling intraperitoneal symbotex mesh fused to small bowel.The patient underwent implantation, on two separate occasions, of symbotex mesh placed in the intraperitoneal position ((b)(6) 2019 and (b)(6) 2021).She developed a symptomatic recurrent incisional hernia after the last implantation.Her symptoms included severe pain and functional disability.At the time of explantation on (b)(6) 2022, the previous meshes were found to be fused to a portion of her small intestine requiring bowel resection as well as complete mesh explantation.She underwent a complex operation and had a complicated postoperative course which could have been avoided, had she not had the recurrence and not have the fusion of mesh to the small bowel.Fda safety report id # (b)(4).
 
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Brand Name
SYMBOTEX MESH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
MEDTRONIC / SOFRADIM PRODUCTION
MDR Report Key15527811
MDR Text Key301118870
Report NumberMW5112372
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 Risk Manager
Type of Report Initial
Report Date 09/28/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/30/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age59 YR
Patient SexFemale
Patient Weight80 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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