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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CR BARD, INC. KUGEL HERNIA MESH
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CR BARD, INC. KUGEL HERNIA MESH Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Disability (2371); Inadequate Pain Relief (2388)
Event Date 04/01/2016
Event Type  Injury  
Event Description

The reporter stated he had inguinal hernia surgery in (b)(6) of this year. The reporter said 4 weeks after the surgery he started having chronic pain in groin area and it goes down to his right thigh. He also said sometimes the pain gets unbearable. The reporter was told by the surgeon that the mesh has migrated to his nerves and that was causing the pain. He went on to say that the surgeon sent him to the pain management clinic to get nerve block treatment. He started the treatment of nerve block but the pain did not go away. Reporter said the physician who did the nerve block treatment told him he may never get better and may never be able to work.

 
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Brand NameKUGEL HERNIA MESH
Type of DeviceKUGEL HERNIA MESH
Manufacturer (Section D)
CR BARD, INC.
MDR Report Key6217843
MDR Text Key63820783
Report NumberMW5067000
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 12/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/30/2016 Patient Sequence Number: 1
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