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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT
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MENTOR WORLDWIDE LLC; BREAST IMPLANT Back to Search Results
Catalog Number UNKNOWN SALINE IMPLANT
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Anaplastic Large Cell Lymphoma (3264)
Date of Event 04/10/2017
Type of Reportable Event Serious Injury
Additional 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 or Problem 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.
 
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Common Device Name
BREAST IMPLANT
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
3041 skyway circle
north irving TX 75038 3540
MDR Report Key6790242
Report Number1645337-2017-00052
Device Sequence Number17011244
Product Code FWM
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2004
Device Explanted Year2016
Reporter Type Manufacturer
Report Source consumer
Type of Report Initial
Report Date (Section B) 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
Operator of Device Lay User/Patient
Device Catalogue NumberUNKNOWN SALINE IMPLANT
Other Device ID NumberUNKNOWN SALINE IMPLANT
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/10/2017
Initial Report FDA Received Date08/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening;
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