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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANT

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MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANT Back to Search Results
Model Number 3502550
Device Problem Component Missing
Event Date 09/21/2017
Event Type  Malfunction  
Manufacturer Narrative

The product is implanted. As a result, no product failure analysis can be conducted and device malfunction cannot be confirmed. 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. Manufacturer's ref. No: (b)(4).

 
Event Description

It was reported by a physician¿s office that a mentor smooth round moderate plus profile saline device was received without the fill valve. Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available. No additional procedure was required, and no adverse event resulted from this incident.

 
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Brand NameMENTOR SMOOTH ROUND MODERATE PLUS PROFILE
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer (Section G)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer Contact
joaquin kurz
3041 skyway circle north
irving , TX 75038
949789-383
MDR Report Key6974905
Report Number1645337-2017-00111
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3502550
Device Catalogue Number3502550
Device LOT Number7478626
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/11/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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