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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC UNKNOWN MENTOR SALINE IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
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MENTOR WORLDWIDE LLC UNKNOWN MENTOR SALINE IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE 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 Codes No Code Available (3191); Anaplastic Large Cell Lymphoma (3264)
Date of Event 01/01/2008
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.(b)(4).The device was not returned to mentor.
 
Event or Problem 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.
 
Additional 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.
 
Additional 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).
 
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Brand Name
UNKNOWN MENTOR SALINE IMPLANT
Common Device Name
PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
3041 skyway circle
north irving TX 75038 3540
MDR Report Key6725178
Report Number1645337-2017-00041
Device Sequence Number12330162
Product Code FWM
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year1986
Device Explanted Year2008
Reporter Type Manufacturer
Report Source company representative,health
Type of Report Initial,Followup,Followup
Report Date (Section B) 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
Operator of Device Health Professional
Device Catalogue NumberUNKNOWN SALINE IMPLANT
Other Device ID NumberUNKNOWN SALINE IMPLANT
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/29/2017
Supplement Date Received by Manufacturer06/29/2017
07/21/2020
Initial Report FDA Received Date07/19/2017
Supplement Report FDA Received Date09/25/2017
07/24/2020
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; Required Intervention;
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