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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIBO INTCO MEDICAL PRODUCTS CO. LTD MCKESSON BRANDS; GLOVE, EXAM VNYL STRTCH PF
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ZIBO INTCO MEDICAL PRODUCTS CO. LTD MCKESSON BRANDS; GLOVE, EXAM VNYL STRTCH PF Back to Search Results
Catalog Number 14-818
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Anaphylactoid (2218)
Event Date 10/16/2019
Event Type  Injury  
Event Description
It was reported that an employee had an allergic reaction when a box of gloves was opened resulting in a visit to the emergency room.Patient was treated for face swelling by administering a steroid shot & benadryl shot, and was given a pepcid pill.Patient was reported to be better the following day and returned to work on the second day.Employee did not don gloves but noticed odor after box was opened.This was a different glove from what is normally ordered.Patient does also have a known latex allergy.
 
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Brand Name
MCKESSON BRANDS
Type of Device
GLOVE, EXAM VNYL STRTCH PF
Manufacturer (Section D)
ZIBO INTCO MEDICAL PRODUCTS CO. LTD
no. 18 qingtian road
qilu chemical industry park
zibo city, shandong 25540 0
CH  255400
MDR Report Key9280000
MDR Text Key165111548
Report Number1451040-2019-00010
Device Sequence Number1
Product Code LYZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number14-818
Device Lot NumberCDI04-29
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date10/17/2019
Device Age6 MO
Event Location Nursing Home
Date Report to Manufacturer10/28/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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