MAUDE Adverse Event Report: JOHNSON AND JOHNSON PROLENE MESH

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Hair Loss (1877); Pain (1994); Vomiting (2144); Burning Sensation (2146); Tingling (2171); Complaint, Ill-Defined (2331); Depression (2361); Numbness (2415)

Event Date 01/11/2006

Event Type  Injury  

Event Description

The reporter said that she is suffering from a lot of complications as a result of mesh implant.She reported that she is having abdominal pain, burning sensation in her esophagus and stomach, cold symptoms that she cannot get rid of, vomiting, pain in the head, hair loss, pain on her legs, bloating, depression, tingling sensation and numbness in her legs.She also said "it feels like a big brick in her stomach".The reporter also said that she had a hysterectomy.

• Brand Name: PROLENE MESH
• Type of Device: MESH
• Manufacturer (Section D): JOHNSON AND JOHNSON
• MDR Report Key: 5768957
• MDR Text Key: 48788584
• Report Number: MW5063205
• 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: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 69