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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number UNK-P-ADVANTAGE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 10/01/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.
 
Event Description
It was reported to boston scientific corporation that a boston scientific mesh product was implanted during a procedure on an unknown date.According to the complainant, post procedure, the patient experienced an unknown injury, and the device had to be removed.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
 
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Brand Name
ADVANTAGE SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
carole morley
300 boston scientific way
,
marlborough, MA 01752
5086834015
MDR Report Key8050527
MDR Text Key126511090
Report Number3005099803-2018-61213
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNK-P-ADVANTAGE
Was Device Available for Evaluation? No
Date Manufacturer Received10/10/2018
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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