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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD SHANNON LIMITED BARD SOFT MESH MESH, SURGICAL, POLYMERIC

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BARD SHANNON LIMITED BARD SOFT MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 0117016
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Unspecified Infection (1930)
Event Date 01/15/2019
Event Type  Injury  
Event Description

Had 2nd surgery; my stomach busted open in february and i got a bad infection which required nursing care, wound vac and another surgery and i lost my belly button. Have a lot of belly pain and setonas and have had multiple tests and a couple different doctors. I have had ultrasound of abdomen and ct scans that have showed it. Fda safety report id# (b)(4).

 
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Brand NameBARD SOFT MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BARD SHANNON LIMITED
MDR Report Key11108042
MDR Text Key225090874
Report NumberMW5098622
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 12/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number0117016
Device Catalogue Number0117016
Device LOT NumberHUCW1436
Was Device Available For Evaluation? Yes
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: 12/31/2020 Patient Sequence Number: 1
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