MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number UNKNOWN SALINE IMPLANT

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

Patient Problem Anaplastic Large Cell Lymphoma (3264)

Event Date 04/10/2017

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

Event Description

It was reported that the patient was diagnosed with bia alcl after using mentor saline implants.No patient contact information was provided.Hence, follow ups for further investigation could not be performed.

• Type of Device: BREAST IMPLANT
• 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: joaquin kurz ; north irving, TX 75038-3540 ; 9497893837
• MDR Report Key: 6790242
• MDR Text Key: 82562795
• Report Number: 1645337-2017-00052
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2017

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN SALINE IMPLANT
• Other Device ID Number: UNKNOWN SALINE IMPLANT
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 08/11/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening