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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 354-4325
Device Problem Incorrect Device Or Component Shipped
Event Date 05/10/2017
Event Type  Malfunction  
Manufacturer Narrative

The product investigation has begun but it has not been completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. Manufacturer's ref. No: (b)(4).

 
Event Description

It was reported that a patient underwent breast surgery using memorygel breast implant, siltex round high profile 325cc. The implant was labeled as 325cc but the implant had volume of 375cc. No patient consequences were reported.

 
Manufacturer Narrative

Manufacturer's ref. #: (b)(4) upon receipt by mentor, the device weighed (b)(4) grams. The gel appeared clear. No foreign material was observed within the device and on the shell surface. The device was received with no labels, upon visual examination pe observed that device appears intact and weighed (b)(4) grams. Volume mark on device is 325cc. No anomalies were discovered. Mentor performs 100% inspection and testing of all devices prior to release. The device history record (dhr) of lot number 7298257 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.

 
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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 Key6622461
Report Number1645337-2017-00036
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number354-4325
Device LOT Number7298257-021
OTHER Device ID Number354-4325
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/19/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2017
Was Device Evaluated By Manufacturer? Yes
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: 06/08/2017 Patient Sequence Number: 1
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