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

Catalog Number UNK_SALINE IMPLANTS

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

Patient Problems Neurological Deficit/Dysfunction (1982); No Code Available (3191)

Event Date 10/15/2003

Event Type  Injury  

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 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.

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
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8001712
• MDR Text Key: 124947320
• Report Number: 1645337-2018-06399
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SALINE IMPLANTS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability