MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESP; GLOVE, PATIENT EXAMINATION, SPECIALTY

Model Number	37415
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: the event date was not reported; the first date of the month of the aware date was selected as an estimate.
Event or Problem 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.

• Brand Name: ESP
• Common Device Name: GLOVE, PATIENT EXAMINATION, SPECIALTY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8080099
• Report Number: 2134265-2018-62841
• Device Sequence Number: 19214179
• Product Code: IWP
• UDI-Device Identifier: 08714729735175
• UDI-Public: 08714729735175
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2019
• Device Model Number: 37415
• Device Catalogue Number: 37415
• Device Lot Number: 0020986742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1