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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD DAVOL VENTRALEX; HERNIA MESH
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BARD DAVOL VENTRALEX; HERNIA MESH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Pain (1994); Seroma (2069); Seroma (2069); Weakness (2145); Depression (2361); Ambulation Difficulties (2544); Ambulation Difficulties (2544)
Event Date 02/01/2017
Event Type  Injury  
Event Description
Reporter stated that in (b)(6), she went to the doctor and was diagnosed with two seromas.One above the mesh and the other below.Her doctor stated that these seroma will resolve by themselves.Reporter went to another doctor due to pain, difficulties breathing and inability to walk.The seroma below resolved on its own but the one above grew bigger.So the doctor drained it.The seroma grew even larger.The dr drained it again.In (b)(6), the doctor removed the seroma and discovered that the stitches used to hold mesh did not dissolve.After a week, the seroma came back larger.Dr.Drained again and pulled 5 (60ml) of dark blood.Reporter wants to go see a hernia doctor today.She stated mesh is supposed to be on recall.
 
Event Description
Add'l info received from reporter for report: mw5073154.Reporter states that two weeks prior to her mesh removal, she felt suicidal and depressed due to the amount of pain and weakness.Reporter explains that the pain felt like she was in "labor for one full year." on (b)(6) 2017 reporter had the hernia mesh and seroma was removed.Reporter states that the pain from the mesh is gone and that she has surgical pain.She will also, need physical therapy to rehabilitate the gastrointestinal damage, muscle weakness to her legs and back.
 
Event Description
Reporter stated that in (b)(6), she went to the doctor and was diagnosed with two seromas.One above the mesh and the other below.Her doctor stated that these seroma will resolve by themselves.Reporter went to another doctor due to pain, difficulties breathing and inability to walk.The seroma below resolved on its own but the one above grew bigger.So the doctor drained it.The seroma grew even larger.The dr drained it again.In (b)(6), the doctor removed the seroma and discovered that the stitches used to hold mesh did not dissolve.After a week, the seroma came back larger.Dr.Drained again and pulled 5 (60ml) of dark blood.Reporter wants to go see a hernia doctor today.She stated mesh is supposed to be on recall.
 
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Brand Name
VENTRALEX
Type of Device
HERNIA MESH
Manufacturer (Section D)
BARD DAVOL
MDR Report Key7006485
MDR Text Key91305936
Report NumberMW5073154
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,Followup
Report Date 11/16/2017
1 Device was Involved in the Event
2 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/07/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/16/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight106
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