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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-M-720163-01
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2019
Event Type  malfunction  
Manufacturer Narrative
Device not returned for evaluation.
 
Event Description
It was reported the patient had an advance xp sling not used due to the sling box not containing the mesh.Another advance xp sling was used to finish the surgery.It was added that the patient is fine.Should additional information be received a supplemental report will be submitted.
 
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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
100 boston scientific way
marlborough MA 01752 1242
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
mike bocchino
10700 bren road w
minnetonka, MN 55343
6515827161
MDR Report Key8511283
MDR Text Key141821814
Report Number2183959-2019-62213
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/12/2019
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 Lay User/Patient
Device Model NumberUNK-M-720163-01
Device Catalogue NumberUNK-M-720163-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/22/2019
Initial Date FDA Received04/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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