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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 3504001BC
Device Problem Shipping Damage or Problem
Event Date 04/10/2017
Event Type  Malfunction  
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) of lot number 7402435 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). The product was not returned to mentor.

 
Event Description

It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it. There was no patient contact reported. The procedure was completed with different device. It is unknown where and how the issue occurred.

 
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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
joaquin kurz
north irving , TX 75038-3540
9497893837
MDR Report Key6818545
Report Number1645337-2017-00061
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 04/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number3504001BC
Device LOT Number7402435-060
OTHER Device ID Number3504001BC
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 Received04/13/2017
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 Initial

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