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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC MENTOR SMOOTH ROUND SPECTRUM PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

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MENTOR WORLDWIDE LLC MENTOR SMOOTH ROUND SPECTRUM PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Catalog Number 350-1490
Device Problem Component Missing
Event Date 10/20/2016
Event Type  Injury  
Manufacturer Narrative

The mentor failure analysis lab received the device for evaluation. The analysis has begun but is not completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. (b)(4).

 
Event Description

It was reported that a (b)(6) female patient underwent stage one reconstruction surgery with saline smooth round spectrum implants. During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. The physician requested for another mentor spectrum package; however, two additional packages also were missing the dome. The physician had to put tissue expanders instead and schedule an additional surgery. This is mdr reportable as an additional procedure was needed to complete a reconstruction surgery.

 
Manufacturer Narrative

On march 27, 2017, mentor worldwide llc has initiated a voluntary remedial action to remove one (1) lot of mentor® saline-filled spectrum¿ breast implants (575cc) lot number 7377332. Some units in the affected lot do not contain the dome pack accessory indicated on the box label. Manufacturer's ref. No: (b)(4).

 
Manufacturer Narrative

This report is to correct supplemental follow-up #2 (report # 1645337-2017-00017). Date of this report on 3500a initial report was correct. Date of this report is (b)(6) 2016. (b)(4).

 
Manufacturer Narrative

Device evaluation summary: it was reported that a (b)(6) female patient underwent stage one reconstruction surgery with saline smooth round spectrum implants. During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. The returned device was not shipped with its box or thermoform. However, the check valve and tubing were received. The device appeared clean and intact. The dome was not received with the rest of the device components. The customer complaint is confirmed. Manufacturer's reference number: (b)(4).

 
Manufacturer Narrative

Date of this report on 3500a initial report. The correct date is 03/24/2017. (b)(4).

 
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Brand NameMENTOR SMOOTH ROUND SPECTRUM
Type of DevicePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
3041 skyway circle
north irving TX 75038 3540
Manufacturer (Section G)
MENTOR WORLDWIDE LLC
3041 skyway circle
north irving TX 75038 3540
Manufacturer Contact
joaquin kurz
north irving , TX 75038-3540
9497893837
MDR Report Key6434405
Report Number1645337-2017-00017
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/21/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number350-1490
Device LOT Number737733-011
OTHER Device ID Number350-1490
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/02/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/24/2017 Patient Sequence Number: 1
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