BOSTON SCIENTIFIC UPSYLON MESH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for BOSTON SCIENTIFIC UPSYLON MESH manufactured by Boston Scientific Corporation.

Event Text Entries

[145541800] In (b)(6) 2017 had pop surgery and sling. Began with pain, bleeding, uti until (b)(6) 2018 when i had surgery to remove mesh that eroded through bladder and vagina. Very difficult and painful surgery. Had stent in ureter and supra pubic catheter for a month. Now i'm so disgusted that since mesh was placed trans abdominally, i have no legal recourse immediately available to me. Mesh erosion - bladder/vagina. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086716
MDR Report Key8623694
Date Received2019-05-17
Date of Report2019-05-16
Date of Event2018-12-11
Date Added to Maude2019-05-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBOSTON SCIENTIFIC UPSYLON MESH
Generic NameGYNECOLOGICAL LAPAROSCOPIC KIT - UPSYLON
Product CodeOHD
Date Received2019-05-17
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2019-05-17

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