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

[19462493] It was reported to boston scientific corporation in 2005, that an enteryx procedure kit was implanted in a patient in 2004, (patient age, gender and weight are unknown). Six injections were performed, delivering a total of 7. 9 cc's of enteryx solution. It was reported that all of these injections were intramuscular and none were submucosal. According to the complainant, the patient experienced an onset of dysphasia the following month. The patient underwent three esophagogastroduodenoscopies (egds) with dilation (2004, two days in 2005) and noted that the dysphasia was still present, but the symptoms had improved. The patient also noted that they did not experience any weight loss.
Patient Sequence No: 1, Text Type: D, B5


[19666619] The device remains implanted in the patient; therefore, a device evaluation cannot be performed. Note: this product was removed from the facility in 2005. Boston scientific corporation no longer produces the reported product.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2008-01895
MDR Report Key1333368
Report Source00,02,05,07
Date Received2009-03-05
Date of Report2005-08-05
Date of Event2004-07-20
Date Mfgr Received2005-08-05
Device Manufacturer Date2003-06-16
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 ContactMR. KEN HIRAKAWA
Manufacturer StreetBOSTON SCIENTIFIC CORPORATION 100 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 Number60803
Device Expiration Date2006-03-31
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. Other 2009-03-05

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