HEDGEHOG SBB-382-50 60252

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-07 for HEDGEHOG SBB-382-50 60252 manufactured by Boston Scientific Corporation.

Event Text Entries

[132247212] The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown. (b)(4). The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[132247213] It was reported to boston scientific corporation that a hedgehog brush was used on (b)(6) 2018. According to the complainant, the bristles from a hedgehog brush detached and became embedded in a suction button. The bristles were removed from the suction button using tweezers. This event occurred during scope reprocessing. There was no patient involvement with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2018-62330
MDR Report Key8222504
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-01-07
Date of Report2019-01-07
Date of Event2018-12-11
Date Mfgr Received2018-12-11
Date Added to Maude2019-01-07
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 Street100 BOSTON SCIENTIFIC WAY ,
Manufacturer CityMARLBOROUGH MA 017521242
Manufacturer CountryUS
Manufacturer Postal017521242
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 Received2019-01-07
Model NumberSBB-382-50
Catalog Number60252
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address100 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 017521242 US 017521242


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.