UPSYLON? UNK760

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-02-28 for UPSYLON? UNK760 manufactured by Boston Scientific - Marlborough.

Event Text Entries

[101233835] As reported by the patient? S attorney, an upsylon y-mesh was implanted. According to the complainant, the patient experienced an unknown injury. All other information is unknown. Should additional relevant details become available; a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2018-00603
MDR Report Key7305229
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2018-02-28
Date of Report2018-02-21
Date Mfgr Received2018-02-21
Date Added to Maude2018-02-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEMP. NANCY CUTINO
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834000
Manufacturer G1PROXY BIOMEDICAL LIMITED
Manufacturer StreetCOILLEACH SPIDDAL
Manufacturer CityGALWAY
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUPSYLON?
Generic NameMESH, SURGICAL, SYNTHETIC
Product CodeKOH
Date Received2018-02-28
Model NumberUNK760
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - MARLBOROUGH
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-02-28

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