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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESP; GLOVE, PATIENT EXAMINATION, SPECIALTY
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BOSTON SCIENTIFIC CORPORATION ESP; GLOVE, PATIENT EXAMINATION, SPECIALTY Back to Search Results
Model Number 37415
Device Problem Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
The event date was not reported; the first date of the month of the aware date was used.
 
Event Description
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.
 
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Brand Name
ESP
Type of Device
GLOVE, PATIENT EXAMINATION, SPECIALTY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8080117
MDR Text Key127454821
Report Number2134265-2018-62846
Device Sequence Number1
Product Code IWP
UDI-Device Identifier08714729735175
UDI-Public08714729735175
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/05/2019
Device Model Number37415
Device Catalogue Number37415
Device Lot Number0020986742
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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