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

Event Text Entries

[20021093] It was reported to boston scientific corporation on september 22, 2005 that an enteryx procedure kit was implanted in a male patient (weight unknown) in 2004. Eight injections were performed, delivering a total of 8 cc's intramuscularly and none were submucosal. According to the complainant, on the next day, the patient experienced odynphagia of moderate intensity that lasted until the following month. The patient also experienced shortness of breath on exertion. A chest x-ray was done that month, and was normal. This event resolved four days later. A reoccurance of odynophaiga of mild intensity began in 2005 and the patient has lost ten pounds associated with the odynophagia. The odynophagia resolved as of three months later, but the patient has mild dysphagia with weight loss. In early 2007, follow-up with the patient reported that the weight loss had stabilized.
Patient Sequence No: 1, Text Type: D, B5


[20113331] Other (pain with swallowing) 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. Product unavailable for analysis.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2008-01935
MDR Report Key1333359
Report Source00,02,05,07
Date Received2009-03-05
Date of Report2005-09-22
Date of Event2004-09-25
Date Mfgr Received2005-09-22
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
Catalog Number7260
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. Other 2009-03-05

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