MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS 3000 ROUND HILE PROFILE

Catalog Number REF 350-3380

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rheumatoid Arthritis (1724); Chest Pain (1776); Fatigue (1849); Hair Loss (1877); Inflammation (1932); Pain (1994); Rash (2033); Tinnitus (2103); Vertigo (2134); Anxiety (2328); Depression (2361); Palpitations (2467); Weight Changes (2607)

Event Date 12/01/2005

Event Type  Injury  

Event Description

I began having rheumatoid symptoms - inflammation, huge knots popping up in various joints, pain on level 10.Had vertigo for over a year, tinnitus, debilitating fatigue, depression, anxiety hair loss, weight gain and loss for no apparent reason, heart palpitations and chest pain, rashes, shingles x3 over the past year.

• Brand Name: BREAST IMPLANTS 3000 ROUND HILE PROFILE
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6893883
• MDR Text Key: 87514800
• Report Number: MW5072419
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• 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: 09/24/2017
• 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
• Device Catalogue Number: REF 350-3380
• Device Lot Number: 244699
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 64