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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 UNKNOWN SALINE IMPLANT
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/13/2017
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. Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer. Manufacturer's ref. (b)(4). The device was not returned mentor.

 
Event Description

It was reported that a patient (unknown age and gender) with mentor breast prostheses (unknown lot # or catalog #) was diagnosed with alcl (diagnosis date unknown). It was reported by the therapeutic goods association (australian authority) that this includes a confirmed pathology report. No further information is known regarding the patient's medical history, status, hospitalizations, medical or surgical interventions that were performed. Manufacturer site is unknown. Multiple attempts have been made to obtain clarification on patient information as well as catalog, lot number and manufacture site of the devices that were used during this procedure. However, no further information has been made available. Mentor reports this event with an abundance of caution.

 
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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 Key6822978
Report Number1645337-2017-00072
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN SALINE IMPLANT
OTHER Device ID NumberUNKNOWN SALINE IMPLANT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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: 08/25/2017 Patient Sequence Number: 1
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