UPSYLON? Y MESH KIT M0068318220

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-03-21 for UPSYLON? Y MESH KIT M0068318220 manufactured by Boston Scientific - Marlborough.

Event Text Entries

[19022194] It was reported to boston scientific corporation that an upsylon y-mesh kit was used during a robotic sacral colpopexy procedure performed on (b)(6) 2014. According to the complainant, during the implantation of the mesh, the trochar from the robot nicked the iliac vessel causing the patient to bleed. The patient required blood transfusions. The procedure was then completed via open surgery. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5


[19275723] The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2014-01417
MDR Report Key3693713
Report Source05,07
Date Received2014-03-21
Date of Report2014-02-26
Date of Event2014-02-26
Date Mfgr Received2014-02-26
Date Added to Maude2014-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactEMP. INGRID MATTE
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? Y MESH KIT
Generic NameGYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
Product CodeOHD
Date Received2014-03-21
Model NumberM0068318220
OperatorPHYSICIAN
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. Required No Informationntervention 2014-03-21

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