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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS PERIGEE SYSTEM WITH INTEPRO
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AMERICAN MEDICAL SYSTEMS, INC. AMS PERIGEE SYSTEM WITH INTEPRO Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Emotional Changes (1831); Pain (1994); Discomfort (2330)
Event Type  Death  
Event Description
It was reported by the plaintiff's atty that the plaintiff allegedly experienced emotional distress and a product problem.It was also reported that the plaintiff experienced dyspareunia, discomfort and pain.Furthermore, it was reported that the plaintiff died.No cause of death reported.Related to mfr report 2183959-2014-39531 and 2183959-2014-39535.
 
Manufacturer Narrative
This was initially reported on the summary report dated (b)(6) 2014 under exemption (b)(4).Lawyer filed report.
 
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Brand Name
AMS PERIGEE SYSTEM WITH INTEPRO
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren road west
minnetonka MN 55343
Manufacturer Contact
sharon zurn, dir, qual compl
10700 bren road west
minnetonka, MN 55343
9529306347
MDR Report Key4377566
MDR Text Key19315952
Report Number2183959-2014-39532
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082387
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/11/2013
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? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/11/2013
Initial Date FDA Received12/30/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PROLENE; MONARC; ELEVATE
Patient Outcome(s) Death;
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