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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD DAVOL 3DMAX HERNIA MESH

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BARD DAVOL 3DMAX HERNIA MESH Back to Search Results
Device Problem Folded (2630)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Foreign Body In Patient (2687)
Event Date 10/19/2017
Event Type  Injury  
Event Description

I have really bad pains in the left inguinal region where i had prior surgery for an inguinal hernia. Seen surgeon who ordered cat scan. Found out that hernia mesh was folded. Had surgery to remove it but a piece was left on the inguinal ligament. I have ilioinguinal and iliohypogastric neuroglia. I have been prescribed a walking cane to help me walk. I am in pain 24/7 and the pain is worse in the evening hours. I am still going through the diagnosis stages, so i may discover more damage.

 
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Brand Name3DMAX HERNIA MESH
Type of Device3DMAX HERNIA MESH
Manufacturer (Section D)
BARD DAVOL
MDR Report Key7227905
MDR Text Key98708468
Report NumberMW5074955
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 01/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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: 01/29/2018 Patient Sequence Number: 1
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