MAUDE Adverse Event Report: SYSTEM, X-RAY, MAMMOGRAPHY

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

Patient Problems Pain (1994); Swelling (2091); Deformity/ Disfigurement (2360)

Event Date 10/04/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, i went for a mammogram at (b)(6) hospital in (b)(6).They were advised i have implants.That evening i was in terrible pain both breasts.They were both swollen and hard (i don't take medication of any kind.) i took ibuprofen and/or aleve.Later days i realized the right implant was broke.The pain on both sides continued.With many calls i finally got to speak to the tech who controlled the machine - (b)(6).I told her what happened.She referred me to (b)(6), i told her what happened and of the pain i was in.Nothing happened.I then called (b)(6 )- chief nurse administrator (b)(6).I told him what happened and of the pain i was in.He said he would call me back.But did not.My husband then called (b)(6) c.E.O., of the hospital (b)(6) and left message to call him back.Instead (b)(6) called back chief quality officer (b)(6).After repeating what happened and of the pain i am in, she suggested i see a doctor.Because of pain i was experiencing i went to (b)(6) center to dr (b)(6).There i was referred to plastic surgeon.I saw dr.(b)(6).He confirmed the right implant was ruptured.He referred me to plastic surgeon.A copy of the report was sent to (b)(6).As of today (b)(6) 2017, no reply and i remain in terrible pain, and disfigured or deformed.I feel each and every one of these people are being obstructionist in the process.After being alerted to the situation, the hospital or staff have not taken responsibility for the problem or pain this is causing me, nor the hardship i am on a fixed income.I feel the hospital should cover all costs of the plastic surgery.This is not covered by medicare or my insurance.Extreme pain and deformed.Was someone operating the medical device when the problem occurred: yes.If yes, who was using it: tech - (b)(6).

• Brand Name: SYSTEM, X-RAY, MAMMOGRAPHY
• Type of Device: SYSTEM, X-RAY, MAMMOGRAPHY
• MDR Report Key: 6371670
• MDR Text Key: 69010001
• Report Number: MW5068208
• Device Sequence Number: 1
• Product Code: IZH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALEVE; IBUPROFEN; TYLENOL
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 64