Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ADVANCE MALE SLING SYSTEM; SURGICAL MESH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AMERICAN MEDICAL SYSTEMS (MN) AMS ADVANCE MALE SLING SYSTEM; SURGICAL MESH Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Incontinence (1928)
Event Date 09/23/2009
Event Type  Injury  
Event Description
It was reported that the patient underwent an alternative incontinence device implantation after having a previous unknown sling.It was later reported on (b)(6) 2015 that the prior sling was an ams advance sling.It was noted that the level of incontinence initially improved and now is worse, and the sling would be removed on (b)(6) 2015.No additional patient complications were reported in relation to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AMS ADVANCE MALE SLING SYSTEM
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
sharon zurn
10700 bren road w
minnetonka, MN 55343
9529306000
MDR Report Key4846618
MDR Text Key5810973
Report Number2183959-2015-00242
Device Sequence Number1
Product Code OTM
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 Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/09/2015
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? Yes
Initial Date Manufacturer Received 05/27/2015
Initial Date FDA Received06/16/2015
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) Hospitalization; Required Intervention;
Patient Age56 YR
-
-