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 00,02,05,07 report with the FDA on 2009-02-26 for ENTERYX PROCEDURE KIT M00572600 7260 manufactured by Boston Scientific Corporation- Marlborough.

Event Text Entries

[1052862] It was reported to boston scientific corporation in 2005, that a patient underwent an enteryx procedure in 2004. According to the complainant, during the patient's 6 month and 12 month follow up appointments, the patient complained of difficulty and pain with swallowing. Reportedly, the patient indicated the symptoms were incapacitating and that they were unable to do daily activities.
Patient Sequence No: 1, Text Type: D, B5


[8187296] Other (pain with swallowing). The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date are unknown. The device remains implanted in the patient; therefore, a device evaluation cannot be performed. Note: this product was removed from the global market in 2005. Boston scientific corporation no longer produces the reported product. Product unavailable for analysis.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2008-05702
MDR Report Key1326403
Report Source00,02,05,07
Date Received2009-02-26
Date of Report2005-03-16
Date of Event2004-09-02
Date Mfgr Received2005-03-16
Date Added to Maude2009-02-26
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 Received2009-02-26
Model NumberM00572600
Catalog Number7260
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 2009-02-26

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