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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
Model Number 3501660
Device Problem Material Rupture (1546)
Patient Problem No Code Available (3191)
Event Date 06/08/2020
Event Type  Injury  
Manufacturer Narrative

At the time of this report, mentor has received no information regarding explantation or an expected explantation date. It is unknown at this time if the device will be made available for return. As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made. As such, the investigation will be closed. If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate. A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint. In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures. Reason for device explant and/or reoperation: n/a. Manufacturer¿s reference number: (b)(4).

 
Event Description

It was reported that a (b)(6) year-old female patient underwent a breast augmentation primary with a mentor smooth round moderate profile 375cc and suffered from a deflation on the right side. At the time of this report, mentor has received no information regarding explantation or an expected explantation date.

 
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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
Manufacturer (Section G)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer Contact
gabriel alfageme
3041 skyway circle north
irving, TX 75038
949789-868
MDR Report Key10216211
MDR Text Key197090528
Report Number1645337-2020-08085
Device Sequence Number1
Product Code FWM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP990075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2016
Device MODEL Number3501660
Device Catalogue Number3501660
Device LOT Number6617529
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/09/2012
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: 06/30/2020 Patient Sequence Number: 1
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