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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

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MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Catalog Number 3501655
Device Problem Device Contamination with Chemical or Other Material
Event Date 11/01/2016
Event Type  Injury  
Manufacturer Narrative

The product investigation has begun but it has not been completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. The device history record (dhr) of lot number 5547192 was reviewed and no anomalies were found related to this complaint. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. (b)(4).

 
Event Description

It is reported that a patient had both mentor implants sal smooth rnd diap 350cc (catalog#3501655; lot# : 5547192-088) removed due to severe nipple pain, body was rejecting implants. Patient kept implants. Patient had implants in for 10 yrs. Mold was reported in the valve and on the outside of the implant. Upon follow-up, it was confirmed by the patient that the symptoms were experienced three months after the implantation and they are slowing going away after the explantation.

 
Manufacturer Narrative

In the initial report, medwatch # 1645337-2017-00062 submitted 8/18/2017, it was mistakenly stated that the device had been returned to mentor, and that the investigation was in progress. However, the device was not actually returned. Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. As such, the investigation will be closed. If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate. The device history record (dhr) was reviewed and no anomalies were found related to this complaint. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. (b)(4).

 
Event Description

It was reported that a (b)(6) female patient who underwent breast augmentation procedure in 2005 with mentor smooth round moderate profile (catalog # 3501655) reported multiple symptoms that began right after implantation. The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness. The patient underwent explantation procedure on (b)(6) 2016. It was reported that the inside of the valve and the outside of the implant had mold. The implants were intact upon explantation. The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation.

 
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Brand NameMENTOR SMOOTH ROUND MODERATE PROFILE
Type of DevicePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038 3540
Manufacturer (Section G)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038 3540
Manufacturer Contact
joaquin kurz
3041 skyway circle north
irving , TX 75038-3540
9497893837
MDR Report Key6819169
Report Number1645337-2017-00062
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/01/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/29/2008
Device Catalogue Number3501655
Device LOT Number5547192
OTHER Device ID Number3501655
Was Device Available For Evaluation? No
Date Returned to Manufacturer06/12/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/30/2004
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: 08/24/2017 Patient Sequence Number: 1
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