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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

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MENTOR TEXAS UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Catalog Number UNK_SALINE IMPLANTS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neurological Deficit/Dysfunction (1982); No Code Available (3191)
Event Date 10/15/2003
Event Type  Injury  
Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made. As such, the investigation will be closed. If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate. Since no lot number was provided, no device history record (dhr) review could be performed. Concomitant medical products: saline mentor breast implant of unknown type. Note: the affected devices were mentor saline smooth round, catalog number and lot number are unknown. The event was reported previously to fda by the patient. (b)(4).
 
Event Description
It was reported that a female patient underwent a breast augmentation with saline mentor breast implants of unknown type and experienced digestive issues, joint problems, lowered immune system, food sensitivities. As a result, the patient had undergone explantation on (b)(6) 2018. This medwatch report is for the right breast implant.
 
Manufacturer Narrative
On 11/9/18, it was reported to mentor that the that a patient reported unexplained systemic symptoms, which included but not limited to fatigue, anxiety depression, stress, muscular and joint pain, , neurasthenia, paresthesia, hair loss, memory loss, fever, sweating, sleeping disorder, mental concentration impaired cognitive and dermatological symptoms. Medical device removal was required. No further information is available at this time. Manufacturer¿s reference number: (b)(4).
 
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Brand NameUNKNOWN SALINE IMPLANTS
Type of DevicePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
MDR Report Key8001712
MDR Text Key124947320
Report Number1645337-2018-06399
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 10/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SALINE IMPLANTS
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/24/2018 Patient Sequence Number: 1
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