MAUDE Adverse Event Report: ETHICON MESH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Nausea (1970); Nerve Damage (1979); Rash (2033); Lethargy (2560)

Event Date 11/24/2015

Event Type  Injury  

Event Description

Hernia repair.About 10 days after repair using ethicon mesh from johnson and johnson, i started having severe skin rashes, fatigue, lethargy and felt nauseous all the time.Eventually, the rash and nerve pain became so severe that after 90 days, my surgeon removed the mesh.No i am out of work for months, two deductibles, and probably have permanent nerve damage from this mesh.Take it off the market!!.

• Brand Name: MESH
• Type of Device: MESH
• Manufacturer (Section D): ETHICON
• MDR Report Key: 5532334
• MDR Text Key: 41416856
• Report Number: MW5061303
• 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: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 86