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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN, INC. NATRELLE SALINE - FILLED BREAST IMPLANT

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ALLERGAN, INC. NATRELLE SALINE - FILLED BREAST IMPLANT Back to Search Results
Model Number STYLE # 468
Event Date 04/01/2010
Event Type  Injury  
Event Description

On (b)(6) 2010, diagnosed with anaplastic large cell lymphoma (alcl) alk-negative. Possibly related or caused by breast implants received in (b)(6) 2002 for augmentation. Experienced complications with left implant diagnosed as capsular contraction. Implant replaced on (b)(6) 2008. Still experiencing capsular contraction after replacement. (b)(6) 2010 - (b)(6) 2011: received 12 doses of chemotherapy, received 20 doses of radiation therapy. Preparing for stem cell transplant scheduled for (b)(6) 2011. (b)(6) 2010: needle biopsy - diagnosis lymphoma. (b)(6) 2010: surgical biopsy - diagnosis alcl. (b)(6) 2010: surgical biopsy - diagnosis alcl.

 
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Brand NameNATRELLE
Type of DeviceSALINE - FILLED BREAST IMPLANT
Manufacturer (Section D)
ALLERGAN, INC.
irvine CA
MDR Report Key2030915
Report NumberMW5019936
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/16/2011
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received03/17/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSTYLE # 468
Device LOT NumberRIGHT: 579142
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 03/17/2011 Patient Sequence Number: 1
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