ENTERYX PROCEDURE KIT M00572600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,02,05,07 report with the FDA on 2009-03-05 for ENTERYX PROCEDURE KIT M00572600 manufactured by Boston Scientific Corporation- Marlborough.

Event Text Entries

[1068129] It was reported to boston scientific corporation on august 15, 2005 that an enteryx procedure kit was implanted in a patient in 2005 (patient age, gender and weight are unknown). Eight injections were performed, delivering a total of 6. 0cc's of enteryx solution to the patient. Of the total solution delivered, 2. 8cc's were injected submucosally. According to the complainant, the patient experienced bleeding from the injection site of mild intensity on the day of the procedure. The patient was treated with an injection of 8. 0cc's of epinephrine injected into the bleeding site and the bleeding had resolved before the scope was removed from the site. The patient was reported to be doing fine and no dilations were required. No weight loss was reported by the patient.
Patient Sequence No: 1, Text Type: D, B5


[8252114] The device remains implanted in the patient; therefore, a device evaluation cannot be performed. Note: this product was removed from the global market in september 2005. Boston scientific corporation no longer produces the reported product.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2008-01924
MDR Report Key1333204
Report Source00,02,05,07
Date Received2009-03-05
Date of Report2005-08-15
Date of Event2005-08-04
Date Mfgr Received2005-08-15
Device Manufacturer Date2004-06-24
Date Added to Maude2009-03-05
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 ContactKEN HIRAKAWA
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086836264
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberZ-0040-06
Event Type3
Type of Report3

Device Details

Brand NameENTERYX PROCEDURE KIT
Generic NameCERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES
Product CodeLMN
Date Received2009-03-05
Model NumberM00572600
Lot Number40611
Device Expiration Date2006-10-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION- MARLBOROUGH
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2009-03-05

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