MAUDE Adverse Event Report: SIENTRA IMPLANTS BREAST; BREAST IMPLANTS

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Hair Loss (1877); Pain (1994); Visual Impairment (2138)

Event Date 11/04/2014

Event Type  Injury  

Event Description

Two months after implant i had severe sores appear all over body, intense fatigue, swallow and breathing problems, chronic cough, hair loss, vision problems, eye pain, atheistic pain, pain in chest.

• Brand Name: IMPLANTS BREAST
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 5267525
• MDR Text Key: 32749435
• Report Number: MW5058291
• Device Sequence Number: 1
• Product Code: MRD
• 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: 12/01/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 62