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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS APOGEE PC WITH INTEXEN LP; SURGICAL MESH
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AMERICAN MEDICAL SYSTEMS (MN) AMS APOGEE PC WITH INTEXEN LP; SURGICAL MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Breast Cancer (1759); Death (1802); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Injury (2348); Prolapse (2475)
Event Type  Death  
Event Description
It was reported by the plaintiff's attorney that the plaintiff allegedly experienced physical pain and suffering, permanent injury, infections, recurring prolapse, abdominal, vaginal and lower back pain and urinary problems.Furthermore, it was reported that the plaintiff died.The cause of death reported was breast cancer.Related to mfr# 2183959-2016-00002, 2183959-2016-00003.
 
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Brand Name
AMS APOGEE PC WITH INTEXEN LP
Type of Device
SURGICAL MESH
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS (MN)
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
AMERICAN MEDICAL SYSTEMS (MN)
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
erika merrick
10700 bren road w
minnetonka, MN 55343
9529306000
MDR Report Key5340301
MDR Text Key34916624
Report Number2183959-2016-00001
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2012
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
Initial Date Manufacturer Received 12/22/2015
Initial Date FDA Received01/04/2016
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
PERIGEE
Patient Outcome(s) Death;
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