MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Anxiety (2328); Arthralgia (2355); Depression (2361); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 05/01/2016

Event Type  Injury  

Event Description

Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction.

• Brand Name: BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6553864
• MDR Text Key: 74846425
• Report Number: MW5069638
• Device Sequence Number: 1
• Product Code: FWM
• 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: 05/06/2017
• 2 Devices were Involved in the Event: 1 2

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 5-HTP.; ADRENAL; CHASTE TREE; GLUTHATHIONE; IRON; MACA ROOT; OTC MEDS: MULTIVITAMIN; RX MEDS: NA; VITAMIN D
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 24 YR
• Patient Weight: 64