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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. KUGEL HERNIA PATCH MESH, SURGICAL, POLYMERIC

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C.R. BARD, INC. KUGEL HERNIA PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Lot Number HUAX2001
Device Problem Hole In Material (1293)
Patient Problem Perforation (2001)
Event Date 01/23/2017
Event Type  Injury  
Event Description
Mk patch use for incarcerated left inguinal hernia repair. Patient returned to 4 days post surgery for repair of bladder perforation and retrieval of mesh within the bladder. An approximate 1cm hole was identified in the bladder wall.
 
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Brand NameKUGEL HERNIA PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
C.R. BARD, INC.
8195 industrial blvd.
covington GA 30014
MDR Report Key6629459
MDR Text Key77220077
Report Number6629459
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Lot NumberHUAX2001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/06/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer06/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/09/2017 Patient Sequence Number: 1
Treatment
NO
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