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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT

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MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT Back to Search Results
Catalog Number 3504001BC
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Code Available (3191)
Event Date 02/17/2017
Event Type  Injury  
Manufacturer Narrative
The device history record (dhr) review for this device was completed on 10/12/2017. The manufacturing and expiration dates of the device were also made available, as a result, the manufacturing date, expiration date and udi fields have been updated. The device history record (dhr) of lot number 6472266 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).
 
Manufacturer Narrative
Device analysis: since the product was not returned for evaluation no product failure analysis can be conducted, and no determination of possible contributing factors could be made. No related complaints were found for this lot number. If the product is received in the future the investigation will continue. The device history record (dhr) of lot number 6472266 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. There are multiple controls within the manufacturing process. At multiple points the devices are processed to ensure any foreign matter, particulates or contaminants are removed or 100% visually inspected for any defects including foreign matter or particulates and subsequently rejected when identified. The application failure modes and effects analysis (afmea) was reviewed for the defect in question (foreign matter/mold) with the hazard risk was determined to be as low as possible (alap), with no further action required. Manufacturer¿s reference number: (b)(4).
 
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) review is in progress. Once completed, the information will be submitted in a supplemental. (b)(4).
 
Event Description
It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. She experienced breast asymmetry (the right breast was lower than the left breast) on (b)(6) 2011, so the patient underwent a revision procedure on (b)(6) 2017 in (b)(6). During this procedure, the surgeon noted that the right breast was discolored (brown). Per patient, the physician woke her up in the middle of the procedure informing her of the discoloration and asked her if he could replace them, therefore the patient underwent bilateral replacement. The patient believes that the discoloration is a fungus growth inside the right device. Per patient, the physician believes the right device was defective. The patient did not report any other symptoms and did not want to return the devices back for failure analysis. Physician did not perform any pathology tests. The left device was not discolored. No deflation were found on both devices.
 
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Brand NameMENTOR MEMORYGEL BREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer Contact
joaquin kurz
3041 skyway circle north
irving, TX 75038
650687-492
MDR Report Key6906512
MDR Text Key109264540
Report Number1645337-2017-00110
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
PMA/PMN Number
P030053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2016
Device Catalogue Number3504001BC
Device Lot Number6472266
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2011
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/29/2017 Patient Sequence Number: 1
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