MAUDE Adverse Event Report: MENTOR SALINE HIGH PROFILE IMPLANTS

Device Problems Contamination (1120); Material Disintegration (1177); Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problems Fatigue (1849); Muscle Weakness (1967); Toxicity (2333); Fungal Infection (2419); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 03/01/2004

Event Type  Injury  

Event Description

Mold chest wall infection from defective implants with leaking valves.Developed mold and debris inside of implants.Toxins poisoned my body.I developed a mold chest wall infection.My muscles became so weak that i am now in a wheelchair.Other issues such as vision problems and constant fatigue.Loss of fine motor skills.Explant (b)(6) 2016.Product defect (leaking valves - mentor saline high profile).Batches of mentor saline implants from 2004 and 2004 had leaking valves.Mold chest wall infection.Toxins leaking out so extensive that it put me in a wheelchair.All of the above on surgical report.

• Brand Name: SALINE HIGH PROFILE IMPLANTS
• Type of Device: SALINE HIGH PROFILE IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6150759
• MDR Text Key: 61733832
• Report Number: MW5066563
• Device Sequence Number: 2
• Product Code: FWM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/05/2016
• 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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FISH OIL; OTC MEDS: MULTIVITAMIN; RX MEDS: NA
• Patient Outcome(s): Disability
• Patient Age: 34 YR
• Patient Weight: 66