MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC UNKNOWN MENTOR SALINE IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number UNKNOWN SALINE IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Code Available (3191); Anaplastic Large Cell Lymphoma (3264)

Event Date 01/01/2008

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.(b)(4).The device was not returned to mentor.

Event Description

This is event was reported via # mw5023558.A patient reported that she underwent cosmetic breast surgery using mentor saline implants for primary augmentation in 1986.In 2008 she was diagnosed with anaplastic large cell lymphoma.The patient was treated with chemotherapy and radiation therapy.Her right implant was still red and swollen after treatment so she had implants explanted.No contact information was provided in mw report, therefore no further information has been made available.

Manufacturer Narrative

Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.(b)(4).The device was not returned to mentor.

Manufacturer Narrative

On 7/21/2020, mentor became aware that this report is a duplicate of manufacturer's report number 1645337-2012-00007, as well as user-submitted medwatch form number mw5023558.This complaint file will be downgraded, and any additional event information received will be submitted under the original manufacturer's report number given above.Manufacturer's reference numbers: (b)(4).

• Brand Name: UNKNOWN MENTOR SALINE IMPLANT
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: carl hansen ; north irving, TX 75038-3540 ; 9497893858
• MDR Report Key: 6725178
• MDR Text Key: 80442606
• Report Number: 1645337-2017-00041
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN SALINE IMPLANT
• Other Device ID Number: UNKNOWN SALINE IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/19/2017
• Supplement Dates Manufacturer Received: 06/29/2017; 07/21/2020
• Supplement Dates FDA Received: 09/25/2017; 07/24/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention