MAUDE Adverse Event Report: ALLERGAN BREAST IMPLANTS; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Chest Pain (1776); Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)

Event Date 05/16/2015

Event Type  Injury  

Event Description

Mammogram caused further harm after seeing scar tissue from car accident (b)(6) 2009.Out of its place, very painful, all bii symptoms and capsule contracture, and very swollen.Chest pain and pressure on left side, which is injured side.Right side painful and pulling sensations.Also 2 mammograms in 2015 showing scar tissue.Fda safety report id# (b)(4).

• Brand Name: BREAST IMPLANTS
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 15596578
• MDR Text Key: 301847498
• Report Number: MW5112592
• Device Sequence Number: 1
• Product Code: LNH
• 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: 10/09/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: IMITREX; MAXALT; MYRBETRIQ; UBRELVY
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Age: 56 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White