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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC BREAST IMPLANT

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MENTOR WORLDWIDE LLC BREAST IMPLANT Back to Search Results
Catalog Number 3507001BC
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2016
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. (b)(4). The product has not been returned.

 
Event Description

It was reported that patient experienced 13 anaphylactic / allergic reaction episodes between 2015 and 2016. Date of explant is scheduled for (b)(6) 2017. Multiple attempts have been made to obtain clarification on this event. However, no further information has been made available.

 
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).

 
Manufacturer Narrative

On 1/2/2018, mentor became aware that a second device was involved. As a result, manufacturer¿s reference number 1645337-2018-00652 was created to document it. Concomitant products: mentor memorygel smooth round moderate plus profile 700cc gel-filled breast implant, catalog # 3507001bc, lot # 6623741 manufacturer¿s reference number: (b)(4).

 
Manufacturer Narrative

On 1/2/2018, mentor became aware that a second device was involved. As a result, manufacturer¿s reference number 1645337-2018-00652 was created to document it. Concomitant products: mentor memorygel smooth round moderate plus profile 700 cc gel-filled breast implant, catalog # 3507001bc, lot # 6623741. (b)(4).

 
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Type of DeviceBREAST IMPLANT
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
carl hansen
north irving , TX 75038-3540
9497893858
MDR Report Key6795847
Report Number1645337-2017-00054
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/20/2019
Device Catalogue Number3507001BC
Device LOT Number6855894-063
OTHER Device ID Number3507001BC
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/20/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/15/2017 Patient Sequence Number: 1
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