MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Model Number SALINE FILLED

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Incontinence (1928); Burning Sensation (2146); Cancer (3262)

Event Date 10/10/2008

Event Type  Injury  

Event Description

Teague urinary incontinence, dry skin, sjogren's autoimmune, hair loss, burning around the breast tissue, two air forms of thyroid cancer, chronic fatigue.

• Brand Name: BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6529922
• MDR Text Key: 74123180
• Report Number: MW5069430
• Device Sequence Number: 1
• Product Code: FTR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/26/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SALINE FILLED
• Device Catalogue Number: REF 350-1690
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: OMEGA FISH OIL. ; RX MEDS: 14 MEDS.
• Patient Outcome(s): Other; Disability
• Patient Age: 55 YR
• Patient Weight: 68