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U.S. Department of Health and Human Services

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

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MENTOR TEXAS MENTOR SALINE SMOOTH ROUND MODERATE PROFILE IMPLANTS BREAST IMPLANT Back to Search Results
Catalog Number 350-1640
Device Problem Device Contamination with Chemical or Other Material
Event Date 01/21/2017
Event Type  Injury  
Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a. 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. The device history record (dhr) review is in progress. Once completed, the information will be submitted in a supplemental. This complaint is related to the other mdr for the other implant on the same patient: (b)(4). Manufacturer's ref. No: (b)(4).

 
Event Description

It was reported that a female patient (age: unk) underwent a breast cosmetic surgery with mentor saline implants in (b)(6) 2001. Recently she had implants explantation for unknown reason. During explantation, the physician observed mold in devices. No further information is available at present.

 
Manufacturer Narrative

An attempt was made to submit this report on 09/20/2017. However, due to an outage affecting the esg or the cdrh emdr processing system we were unable to meet the report submission due date. (b)(4).

 
Manufacturer Narrative

This supplemental report is to provide dhr. The device history record (dhr) of lot number 223220 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).

 
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Brand NameMENTOR SALINE SMOOTH ROUND MODERATE PROFILE IMPLANTS
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer Contact
joaquin kurz
3041 skyway circle north
irving , TX 75038
650687-492
MDR Report Key6884038
Report Number1645337-2017-00108
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/15/2005
Device Catalogue Number350-1640
Device LOT Number223220
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/21/2017 Patient Sequence Number: 1
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