• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS L.P. MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MENTOR TEXAS L.P. MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED Back to Search Results
Model Number 3503751BC
Event Date 06/19/2017
Event Type  Malfunction  
Event Description

During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. The implant packaging was opened and inspected on the sterile field table in the or. The surgeon noticed a piece of plastic that was attached to the outside of the shell. Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid. The implant was removed from the field and a new implant was used for the procedure. The device was given to the manufacturer representative by the or staff for further investigation. No harm came to the patient. Manufacturer requested implant and packaging directly from or team to investigate.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMENTOR MEMORYGEL BREAST IMPLANT
Type of DevicePROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
Manufacturer (Section D)
MENTOR TEXAS L.P.
3041 skyway cir n.
irving TX 75038
MDR Report Key6666640
Report Number6666640
Device Sequence Number1
Product CodeFTR
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2017
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date06/01/2018
Device MODEL Number3503751BC
Device Catalogue Number3503751BC
Device LOT Number6726311
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/21/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/21/2017
Device Age0 yr
Event Location Hospital
Date Report TO Manufacturer06/21/2017
Was Device Evaluated By Manufacturer? No Answer Provided
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: 06/26/2017 Patient Sequence Number: 1
Treatment
NOT APPLICABLE.
-
-