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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
Device Problem Inflation Problem (1310)
Patient Problems Cancer, Other (1760); Swelling (2091)
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
MDR Text Key17890611
Report Number1645337-2010-00027
Device Sequence Number1
Product Code FWM
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
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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