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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS RETROARC RETROPUBIC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

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AMERICAN MEDICAL SYSTEMS (MN) AMS RETROARC RETROPUBIC SLING SYSTEM; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Material Rupture (1546)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Same patient as mfr #: 2183959-2015-00093.It was reported that during a revision surgery for retention, the physician placed a small hemostat between the mesh and urethra to loosen the sling and it tore in the midline.No further patient complications were reported in relation to this event.
 
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Brand Name
AMS RETROARC RETROPUBIC SLING SYSTEM
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS (MN)
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
AMERICAN MEDICAL SYSTEMS (IRELAND)
athlone business & tech park
garrycastle, dublin road
co. westmeath MN 55343
EI   55343
Manufacturer Contact
sharon zurn
10700 bren road w
minnetonka, MN 55343
9529306000
MDR Report Key4602687
MDR Text Key20753081
Report Number2183959-2015-00092
Device Sequence Number1
Product Code OTN
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,Followup
Report Date 02/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/06/2015
Initial Date FDA Received03/16/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/05/2015
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) Required Intervention;
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