MAUDE Adverse Event Report: MENTOR TEXAS NON MENTOR PRODUCT; EXPANDER, SKIN, INFLATABLE

Catalog Number NON MENTOR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems No Patient Involvement (2645); No Code Available (3191); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.The lot number reported could not be associated to any products; therefore, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: breast cancer.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a female patient underwent breast implant reconstruction surgery with an unspecified mentor tissue expander and has experienced left breast cancer.The patient underwent exchange of the device on (b)(6) 2019 with replacement to a mentor memorygel breast implant 700cc, catalog number 3507001bc, serial number (b)(4) (l) and a mentor memorygel breast implant 190cc, catalog number 3507190mc, serial number (b)(4).

Manufacturer Narrative

On mar 16 2020, a non-mentor device was received.The lot number initially reported matches the lot number for the device received.No further investigation will take place, and no further supplemental reports will be sent.Manufacturer¿s reference number: (b)(4).

• Brand Name: NON MENTOR PRODUCT
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9832776
• MDR Text Key: 183547449
• Report Number: 1645337-2020-04191
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NON MENTOR
• Device Lot Number: 31877197
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention