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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD / DAVOL INC., SUB. C.R. BARD, INC. BARD MARLEX 3" X 6" MESH MESH, SURGICAL, POLYMERIC

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BARD / DAVOL INC., SUB. C.R. BARD, INC. BARD MARLEX 3" X 6" MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Lot Number HUW11295
Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)
Patient Problem Erosion (1750)
Event Date 09/11/2020
Event Type  Injury  
Event Description

Ob/gyn found mangled ball of mesh that's eroding into organs. Surgery with a urogynecologist is required and currently being scheduled. Bard marlex that was used during radical hysterectomy. Fda safety report id# (b)(4).

 
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Brand NameBARD MARLEX 3" X 6" MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BARD / DAVOL INC., SUB. C.R. BARD, INC.
MDR Report Key10726089
MDR Text Key213007515
Report NumberMW5097420
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 10/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date01/30/2018
Device LOT NumberHUW11295
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: 10/22/2020 Patient Sequence Number: 1
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