ESP? M001201111 20-111

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 2018-05-08 for ESP? M001201111 20-111 manufactured by Boston Scientific - Costa Rica (coyol).

Event Text Entries

[107756659] Device evaluated by mfr: the device has not been received for analysis. The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[107756660] I was reported that when using the esp? Specialty gloves, the physician would have to use multiple pairs during a procedure due to tearing at the seams. No patient or provider complications were reported to be related to this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2018-01292
MDR Report Key7495650
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-05-08
Date of Report2018-04-11
Date Mfgr Received2018-04-11
Date Added to Maude2018-05-08
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 ContactEMP. SONALI ARANGIL
Manufacturer StreetONE SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634941700
Manufacturer G1BOSTON SCIENTIFIC - COSTA RICA (COYOL)
Manufacturer Street2546 FIRST STREET PROPARK FREE ZONE
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameESP?
Generic NameGLOVE, PATIENT EXAMINATION, SPECIALTY
Product CodeLZC
Date Received2018-05-08
Model NumberM001201111
Catalog Number20-111
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - COSTA RICA (COYOL)
Manufacturer Address2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-08

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