MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN SALINE IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	UNKNOWN SALINE IMPLANT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Reaction (1733); Swollen Lymph Nodes (2093); No Code Available (3191)
Date of Event	04/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).
Event or Problem Description
It was reported (via fda medwatch) that a female patient of unknown age who underwent breast prostheses implantation with mentor saline implants on (b)(6) 2000 experienced the following: "in 2000 i got mentor spectrum adjustable implants; 5 years ago i started getting sick.I'm getting worse.I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work.Hair falling out, weight gain, lymph nodes swollen, breast pain left side.Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane.Headaches, fevers, fatigue, urinate on myself avg 5 times a day.Ibs, osteoporosis, told i have lupus and ra, but negative blood work.Low white blood count.Depression, asthma, hard time breathing at times.I want to get the implants taken out, but can't afford to do so." no product issue, such as rupture, was reported.No date of revision or explantation was reported.This report is for the right implant.
Additional Manufacturer Narrative
On (b)(6) 2018, mentor updated the codification and the code auto immune disorder, and swollen lymph node were mistakenly reported initially and is not required.This report is for the right implant.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNKNOWN SALINE IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8023320
• Report Number: 1645337-2018-06496
• Device Sequence Number: 12452459
• Product Code: FWM
• Combination Product (Y/N): N
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Reporter Type: Manufacturer
• Report Source: consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN SALINE IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/20/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other; Required Intervention; Disability