MAUDE Adverse Event Report: BREAST TISSUE EXPANDERS; EXPANDER, SKIN, INFLATABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Memory Loss/Impairment (1958); Pain (1994); Ambulation Difficulties (2544); Cancer (3262); Peripheral Edema (4578)

Event Date 09/04/2022

Event Type  Injury  

Event Description

My name is (b)(6) and i am not crazy.I am very sick from taking ropinirole or requip and/or risperdal and my legs have been getting worse and worse and i have been very sick and have lost my memory short term but my legs keep getting worse resulting in inability to move at times.Dr (b)(6) keeps increasing dosage and i have lower back pain and feel close to death at times shortness of breath and large limbs and leg swelling.Dr (b)(6) told me that something was wrong and i need to see a neurologist and she helped me see that the rls (restless leg syndrome) was not connected to zoloft or sertraline use but she helped me and i told her i had breast cancer and melanoma and she cared about me as a human being even though i was broke.Dr (b)(6) told me to verify and helped me and i just need help because i took responsibility for a crime in 2015 but i only took part of the money not all.(b)(6) 2008 i had breast cancer surgery but my fbi.Gov report lists me in 2008 as having been arrested and i never had handcuffs on.I felt like giving up but god showed me my life after a crime still had value.I cant be the only one.I just need some help.I want to help those with no options who deserve a second chance.Breast expanders (2nd time).Fda safety report id# (b)(4).

• Brand Name: BREAST TISSUE EXPANDERS
• Type of Device: EXPANDER, SKIN, INFLATABLE
• MDR Report Key: 15380863
• MDR Text Key: 299709689
• Report Number: MW5111940
• Device Sequence Number: 4
• Product Code: LCJ
• 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: 09/04/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: KLONOPIN ; RISPERDAL ; ROPINIROLE; ZOLOFT
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Other; Disability
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White