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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
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
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).
 
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.
 
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Brand NameUNKNOWN MENTOR SALINE IMPLANT
Type of DevicePROSTHESIS, 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 Key6725178
MDR Text Key117912388
Report Number1645337-2017-00041
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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
Date FDA Received07/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN SALINE IMPLANT
Other Device ID NumberUNKNOWN SALINE IMPLANT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2020
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

Patient Treatment Data
Date Received: 07/19/2017 Patient Sequence Number: 1
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