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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD SHANNON LIMITED DAVOL MESH FLAT SHEET 3; MESH, SURGICAL, POLYMERIC
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BARD SHANNON LIMITED DAVOL MESH FLAT SHEET 3; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number LOG912747
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 02/03/2022
Event Type  malfunction  
Event Description
During procedure, surgeon was preparing the mesh for implantation by cutting it to the shape and size needed.He tested the mesh integrity before implanting it in the patient and it began to tear in half.The mesh was removed from the field and a new piece of mesh from a different lot number was used for the procedure.Fda safety report id# (b)(4).
 
Event Description
During procedure, surgeon was preparing the mesh for implantation by cutting it to the shape and size needed.He tested the mesh integrity before implanting it in the patient and it began to tear in half.The mesh was removed from the field and a new piece of mesh from a different lot number was used for the procedure.Fda safety report id# (b)(4).
 
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Brand Name
DAVOL MESH FLAT SHEET 3
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BARD SHANNON LIMITED
MDR Report Key13514279
MDR Text Key285555301
Report NumberMW5107388
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 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLOG912747
Device Lot NumberHUFR1874
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age43 YR
Patient SexMale
Patient Weight101 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
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