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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. SURGICAL MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number REF 0112970
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Pain (1994); Post Operative Wound Infection (2446); Syncope/Fainting (4411); Skin Inflammation/ Irritation (4545)
Event Date 08/20/2019
Event Type  Injury  
Event Description
Caller stated that he was implanted with a mesh on (b)(6) 2019. One on the right side of the groin and another on the left side. Pt stated after implantation he started to experience pain in the groin area. Pt met with his doctor to discuss his symptoms, while he was at the doctor's office he fainted. He was later revived. Patient stated when he got home after meeting with his doctor he noticed that his body is inflamed and red. His son took him to the emergency room where he was admitted to the hospital. He was in the hospital for two weeks because he develop gangrene and his wound was infected. He was placed on antibiotics. He continued to received treatment until his wound is cleared from infection and healed. On (b)(6) 2021 the mesh was explanted.
 
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Brand NameSURGICAL MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
C.R. BARD, INC.
MDR Report Key12954591
MDR Text Key281937358
Report NumberMW5105877
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 Non-Healthcare Professional
Type of Report Initial
Report Date 12/06/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue NumberREF 0112970
Device Lot NumberHUDQ0726 RIGHT
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No

Patient Treatment Data
Date Received: 12/06/2021 Patient Sequence Number: 1
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