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

Catalog Number	UNK_SALINE IMPLANTS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); No Code Available (3191)
Date of Event	10/15/2003
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.Concomitant medical products: saline mentor breast implant of unknown type.Note: the affected devices were mentor saline smooth round, catalog number and lot number are unknown.The event was reported previously to fda by the patient.(b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast augmentation with saline mentor breast implants of unknown type and experienced digestive issues, joint problems, lowered immune system, food sensitivities.As a result, the patient had undergone explantation on (b)(6) 2018.This medwatch report is for the right breast implant.
Additional Manufacturer Narrative
On 11/9/18, it was reported to mentor that the that a patient reported unexplained systemic symptoms, which included but not limited to fatigue, anxiety depression, stress, muscular and joint pain, , neurasthenia, paresthesia, hair loss, memory loss, fever, sweating, sleeping disorder, mental concentration impaired cognitive and dermatological symptoms.Medical device removal was required.No further information is available at this time.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: 8001712
• Report Number: 1645337-2018-06399
• Device Sequence Number: 1702012
• 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: 2003
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: UNK_SALINE IMPLANTS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability