ENTERYX PROCEDURE KIT M00572600 7260

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 2009-03-05 for ENTERYX PROCEDURE KIT M00572600 7260 manufactured by Boston Scientific Corporation- Marlborough.

Event Text Entries

[18514404] It was reported to boston scientific corporation on february 10, 2006 that an eneryx procedure kit was implanted in a female patient (weight is unknown) in 2005. According to the complainant, beginning in three months later, the patient reported experiencing dysphagia of moderate intesity. She had an esophagogastroduodenoscopy (egd) with dilation. The event was reported to be resolved as of the following month.
Patient Sequence No: 1, Text Type: D, B5


[18691504] The lot number is unknown; therefore, the manufacture date cannot be determined. 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. Other : product unavailable for analysis.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2008-02290
MDR Report Key1333648
Report Source05,07
Date Received2009-03-05
Date of Report2006-02-10
Date of Event2005-02-01
Date Mfgr Received2006-02-10
Device Manufacturer Date2004-12-01
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
Catalog Number7260
Lot Number0000041118
Device Expiration Date2006-12-31
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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