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

Catalog Number	UNKNOWN SALINE IMPLANTS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930); No Code Available (3191)
Date of Event	02/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, 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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient who underwent primary breast augmentation on (b)(6) 2009 developed bilateral baker grade unknown capsular contracture.The patient also had low white blood count, positive ana, elevated monocyte level (13%), full body inflammation, massive weight gain, brain fog, tinnitus, major fatigue, memory loss, new onset allergies, skin condition on the knees, rashes, knee/shoulder throbbing, inflamed joints, painful breasts, and hand and "wet" swelling.The patient reported that her blood is "screaming disease and infection." the patient underwent testing but everything returned negative for disease.No product issue, such as rupture, was reported.The root cause of the patient's symptoms are unclear.The patient underwent removal without replacement on (b)(6) 2018.This report is for "the" one of the two implant.
Additional Manufacturer Narrative
On (b)(6) 2019, mentor became aware that this report is a duplicate of manufacturer¿s report number 1645337-2019-09953.This file has been updated to contain the most current and accurate information, and all subsequent regulatory reporting, if applicable, will take place under this report number.The full details of our investigation are below: it was reported that a 31-year-old caucasian female patient underwent primary breast augmentation with two unspecified mentor saline breast implants and suffered bilateral capsular contracture postoperatively.The patient also reported directly to fda via mw5079602 a series of unexplained systemic symptoms, including low white blood cell count, positive ana, elevated monocyte level (13%), full body inflammation, massive weight gain, brain fog, tinnitus, major fatigue, memory loss, new onset allergies, skin condition on the knees, rashes, knee/shoulder throbbing, inflamed joints, painful breasts, and wet/swollen hands.She states in mw5079602 that she believed she had an infection as well.The patient¿s tests returned normal results.On (b)(6) 2018, she underwent bilateral explantation without removal.No device issue, such as rupture, was reported.Upon explantation, the devices were in ¿grossly normal¿ condition, per the patient¿s physician.Reason for device explant and/or reoperation: generalized illness and capsular contracture manufacturer's reference number: (b)(4).

• Brand Name: UNKNOWN SALINE IMPLANTS
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7999163
• Report Number: 1645337-2018-06297
• Device Sequence Number: 1529066
• 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: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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 IMPLANTS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 08/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Disability
• Patient Age: 31 YR