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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE-FILLED BREAST IMPLANT

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MENTOR MENTOR SALINE-FILLED BREAST IMPLANT Back to Search Results
Catalog Number 350-1660
Event Date 06/18/2010
Event Type  Injury  
Event Description

The original purchase date of this device was (b)(6)2004. In (b)(6) 2006, the pt was implanted with mentor siltex saline devices during a revision augmentation procedure. In (b)(6) 2008, the devices were replaced with mentor smooth saline devices due to a left device deflation. In (b)(6) 2010, the pt had both implants removed due to recurring fluid accumulation in the right breast. On (b)(6)2010, the pt was diagnosed with alcl (t-cell lymphoma). No further info is available at this time.

 
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Brand NameMENTOR SALINE-FILLED BREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
irving TX
Manufacturer Contact
christy babb
3041 skyway circle north
irving , TX 75038
9722526060
MDR Report Key1853336
Report Number1645337-2010-00027
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type User facility
Type of Report Initial
Report Date 09/30/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number350-1660
Was Device Available For Evaluation? No
Date Manufacturer Received09/29/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/01/2010 Patient Sequence Number: 1
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