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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
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BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE Back to Search Results
Model Number UNK-P-SLING-MENS ADVANCE XP
Device Problem Premature Activation (1484)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2019
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure involving a sling device, the mesh became detached to the trocar.Another sling was used to complete the surgery.No patient complications were reported.
 
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Brand Name
AMS ADVANCE XP SLING SYSTEM
Type of Device
MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road west
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka, MN 55343
4089353452
MDR Report Key9531931
MDR Text Key175429394
Report Number2183959-2019-68383
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182169
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 12/30/2019
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
Device Model NumberUNK-P-SLING-MENS ADVANCE XP
Device Catalogue NumberUNK-P-SLING-MENS ADVANCE XP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/09/2019
Initial Date FDA Received12/30/2019
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) Hospitalization; Required Intervention;
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