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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS ADVANCE MALE SLING SYSTEM; MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE

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BOSTON SCIENTIFIC - MINNETONKA AMS ADVANCE MALE SLING SYSTEM; MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Urinary Retention (2119)
Event Date 06/14/2018
Event Type  Injury  
Event Description
It was reported the patient had an advance sling implanted approximately one year earlier.The patient was in retention for three days following implant and then was back to baseline after the third day.The patient was implanted with an artificial urinary sphincter device on (b)(6) 2018.No further patient complications were reported in relation to this event.
 
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Brand Name
AMS ADVANCE MALE SLING SYSTEM
Type of Device
MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE
Manufacturer (Section D)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
sharon zurn
10700 bren road w
minnetonka, MN 55343
9529306000
MDR Report Key7658078
MDR Text Key113003919
Report Number2183959-2018-00086
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 06/14/2018
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? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/19/2018
Initial Date FDA Received07/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age82 YR
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