ESP 37415

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 2018-11-16 for ESP 37415 manufactured by Boston Scientific Corporation.

Event Text Entries

[127454821] The event date was not reported; the first date of the month of the aware date was used.
Patient Sequence No: 1, Text Type: N, H10


[127454822] It was reported that several pairs of size 8 esp specialty gloves had been opened and every pair had a hole in the wrist. There were no patient or physician injuries or issues reported to have occurred.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2018-62846
MDR Report Key8080117
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-11-16
Date of Report2018-11-16
Date of Event2018-10-01
Date Mfgr Received2018-10-25
Device Manufacturer Date2017-08-10
Date Added to Maude2018-11-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSONALI ARANGIL
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone6515827403
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street780 BROOKSIDE DRIVE
Manufacturer CitySPENCER IN 47460
Manufacturer CountryUS
Manufacturer Postal Code47460
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameESP
Generic NameGLOVE, PATIENT EXAMINATION, SPECIALTY
Product CodeIWP
Date Received2018-11-16
Model Number37415
Catalog Number37415
Lot Number0020986742
Device Expiration Date2019-02-05
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-16

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