MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	354-4325
Medical Device Problem Code	Incorrect Device Or Component Shipped (2962)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6622461
• Report Number: 1645337-2017-00036
• Device Sequence Number: 15154656
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 354-4325
• Device Lot Number: 7298257-021
• Other Device ID Number: 354-4325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other