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MAUDE Adverse Event Report: MENTOR BREAST IMPLANT
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MENTOR BREAST IMPLANT
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Lot Number
5746062
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems
Gastritis (1874); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994); Palpitations (2467)
Event Date
10/20/2012
Event Type
Injury
Event Description
Ongoing recurrent infections. Abnormal blood test results since 2012. Gi issues, pain. Menstrual period only twice or so a year (started in 2008 after implants). Palpitations.
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Brand Name
BREAST IMPLANT
Type of Device
BREAST IMPLANT
Manufacturer
(Section D)
MENTOR
MDR Report Key
6543640
MDR Text Key
74541124
Report Number
MW5069555
Device Sequence Number
1
Product Code
FWM
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Patient
Type of Report
Initial
Report Date
05/02/2017
2
Devices were Involved in the Event:
1
2
1
Patient was Involved in the Event
Date FDA Received
05/02/2017
Is this an Adverse Event Report?
Yes
Is this a Product Problem Report?
No
Device Operator
Device Lot Number
5746062
Was Device Available for Evaluation?
Yes
Is the Reporter a Health Professional?
No Answer provided
Was the Report Sent to FDA?
Event Location
No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
Patient Treatment Data
Date Received: 05/02/2017 Patient Sequence Number: 1
Treatment
ALEVE; AMBIEN; ATIVAN; IMITREX; TRAMADOL; VITAMIN D
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