MAUDE Adverse Event Report: CR BARD, INC. KUGEL HERNIA MESH

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.

• Brand Name: KUGEL HERNIA MESH
• Type of Device: KUGEL HERNIA MESH
• Manufacturer (Section D): CR BARD, INC.
• MDR Report Key: 6217843
• MDR Text Key: 63820783
• Report Number: MW5067000
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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