HEDGEHOG SBD-289-50 60252

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-11 for HEDGEHOG SBD-289-50 60252 manufactured by Boston Scientific Corporation.

Event Text Entries

[135909119] The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date is unknown. This is a non-sterile device with no expiration date. (b)(4). According to the complainant is not available for return; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[135909120] It was reported to boston scientific corporation that a hedgehog double-end brush was used on (b)(6) 2018. According to the complainant, the bristles of the brush got caught by the elevator inside the scope and detached from the brush head. This event reportedly happened during cleaning, post procedure. It was not reported how the cleaning was completed. There was no serious injury nor any adverse patient effects reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-00594
MDR Report Key8329113
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-02-11
Date of Report2019-02-11
Date of Event2019-01-15
Date Mfgr Received2019-01-15
Date Added to Maude2019-02-11
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 FDA3
Event Location3
Manufacturer ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY ,
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1SUZHOU TEMEIRUI MEDICAL PRODUCTS CO., LTD
Manufacturer StreetNO 699 PINAN ROAD PUZHAUNG LINHU TOWN,
Manufacturer CityWUZHONG DISTRICT, SUZHOU 21505
Manufacturer CountryCH
Manufacturer Postal Code21505
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEDGEHOG
Generic NameACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
Product CodeMNL
Date Received2019-02-11
Model NumberSBD-289-50
Catalog Number60252
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-11

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