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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN UNK SALINE IMPLANT

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ALLERGAN UNK SALINE IMPLANT Back to Search Results
Catalog Number UNK SALINE IMPLANT
Device Problem No Apparent Adverse Event
Event Date 01/01/2012
Event Type  Injury  
Manufacturer Narrative

Device labeling reviewed: there were no reported events of lymphoma/alcl for pts in the a95/r95 study included in the labeling for saline breast implants. The following is a list of potential adverse events that may occur with breast implant surgery. The risks include: implant deflation/leakage, additional surgery, capsular contracture,. "infection, toxic shock syndrome, necrosis, hematoma, seroma, extrusion, breast pain, changes in nipple sensation, changes in breast sensation, dissatisfaction with cosmetic results (wrinkling, folding, displacement, asymmetry, palpability, visibility, ptosis, sloshing), calcific deposits, irritation/inflammation, delayed wound healing, hypertrophic scarring, breast tissue atrophy/chest wall deformity, difficulty/inability in breast feeding, and inability to adequately visualize breast lesions with mammography. In addition to these potential adverse events, there have been concerns with certain systemic diseases.

 
Event Description

Healthcare professional reports a case of lymphoma and other b-symptoms via mw (b)(4) the mw notes that: "the reporter called on behalf of a pt who was diagnosed with alcl. The pt presented with anaplastic large cell lymphoma, diagnosed in 2013. History of hodgkin's lymphoma diagnosed in 2011. These two events came about after the pt underwent breast augmentation in 1994. In 2010, pt presented with an abnormal mammogram performed in 2010. Breast pain, skin color change, skin texture change, and inflowing diffusion form the right breast up to right neck and shoulder. The pt was running a fever throughout the entire process. After an mri and subsequent test, the pt was diagnosed with hodgkin's lymphoma and underwent mantle radiation. In 2012, the pt underwent surgery essentially for a breast mass, but the pt also desired a mastectomy for removal of right and left implants and capsules. The pathology of the operation soon reported that the pt also has alcl; the mass had come from the lymphoma. ".

 
Event Description

This medwatch is for the left side see mfr report # 2024601-2013-00935 for the right side.

 
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Brand NameUNK SALINE IMPLANT
Manufacturer (Section D)
ALLERGAN
boleta CA
Manufacturer Contact
karen herrera
71 s. los carneros rd
boleta , CA 93117
8059615405
MDR Report Key3487103
Report Number2024601-2013-00941
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 10/22/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK SALINE IMPLANT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/07/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/07/2013 Patient Sequence Number: 1
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