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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD BARD 3D MAX MESH

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BARD BARD 3D MAX MESH Back to Search Results
Lot Number HUVI0120
Device Problem Folded (2630)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 02/24/2012
Event Type  Injury  
Event Description
Had bi-lateral hernia surgery with mesh implanted. One large piece of bard 3d mesh used to cover a femoral and inguinal hernia together on the right, and another large piece used to cover two inguinal hernias on the left. Bard 3d max lot huvi0120 and huvj0718 and sorbafix lot huvj0760. Since (b)(6) weeks after surgery, have had tremendous pain in right pelvis to pubic bone and down front of leg, and some burning pain in left pelvis. Also had surgical clips used to hold right peritoneum closed. Surgical report says it "opened during the surgery. ".
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Type of DeviceMESH
Manufacturer (Section D)
MDR Report Key2660967
MDR Text Key2837524
Report NumberMW5026193
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/15/2012
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received07/15/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date09/30/2016
Device Lot NumberHUVI0120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No

Patient Treatment Data
Date Received: 07/15/2012 Patient Sequence Number: 1