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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS SPARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC
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AMERICAN MEDICAL SYSTEMS, INC. AMS SPARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Death (1802); Emotional Changes (1831); Pain (1994); Injury (2348)
Event Type  Death  
Event Description
It was reported that the plaintiff allegedly experienced serious bodily injuries, erosion of bodily tissues, dyspareunia, significant mental and physical pain and suffering.Furthermore, it was reported that the plaintiff died.The cause of death was reported as chronic obstructive pulmonary disease.
 
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 SPARC SLING SYSTEM
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren road west
minnetonka MN 55343
Manufacturer Contact
sharon zurn, director
10700 bren road west
minnetonka, MN 55343
9529306347
MDR Report Key4383533
MDR Text Key5264003
Report Number2183959-2014-32353
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011251
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 03/01/2013
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 03/01/2013
Initial Date FDA Received12/31/2014
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
Patient Outcome(s) Death;
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