MAUDE Adverse Event Report: BARD 3D MAX LARGE

Catalog Number 0115311

Device Problems Folded (2630); Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Headache (1880); Nausea (1970); Pain (1994); Malaise (2359); Reaction (2414)

Event Date 05/08/2015

Event Type  Injury  

Event Description

Had bard 3d max large mesh implanted for alleged left inguinal repair on (b)(6) 2015.My son is (b)(6) years old.Pain increased and spread, became very ill over a 4 month span with constant nausea, constant stabbing headaches that never went away, fatigue, felt like he had the flu with no fever.He ended up bedridden and could not go to school or to his part time job.He felt like he was going to die and the pain became intolerable on top of the illness.I (mom) searched for help to try to get the mesh removed.The original surgeon did not do mesh removals.It took months.I finally found a surgeon in (b)(6) that removed it on (b)(6) 2015.He still has some pain, but is not sick, and is out of bed working again.When removed, no hernia was found, and the mesh was folded in half.He seemed to have had some type of body reaction to the mesh or the mesh was defective and may have had some toxic chemical that did not belong on or in it because he got so ill.The mesh reference number is (b)(4), the lot number is huzb0180, and the expiration date was 2020.I have a picture of the removed mesh that the removal surgeon took.

• Brand Name: 3D MAX LARGE
• Type of Device: 3D MAX LARGE
• Manufacturer (Section D): BARD
• MDR Report Key: 5161653
• MDR Text Key: 28806393
• Report Number: MW5057173
• 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 Family Member or Friend
• Report Date: 10/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/01/2020
• Device Catalogue Number: 0115311
• Device Lot Number: HUZB0180
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 18 YR
• Patient Weight: 66