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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO LTD MCKESSON BRANDS; SHIELD, FACE FULL LENGTH ANTI-FOG
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ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO LTD MCKESSON BRANDS; SHIELD, FACE FULL LENGTH ANTI-FOG Back to Search Results
Catalog Number 16-GDF-01
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 10/28/2022
Event Type  Injury  
Event Description
Customer reported that an employee wore the latex-free mckesson brands face shield for 30 minutes and had an allergic reaction.The patient has a known latex allergy.The following reaction was reported: welted forehead, swollen tongue, slurred speech, flushed skin, brain fuzziness, and exhaustion.User was given benadryl inhouse for the allergic reaction.
 
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Brand Name
MCKESSON BRANDS
Type of Device
SHIELD, FACE FULL LENGTH ANTI-FOG
Manufacturer (Section D)
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO LTD
no. 10 beiyun ave
huangyan, taizhou 31802 0
CH  318020
MDR Report Key15826520
MDR Text Key303933843
Report Number1451040-2022-00059
Device Sequence Number1
Product Code LYU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number16-GDF-01
Device Lot NumberCGDB05-06
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2022
Distributor Facility Aware Date10/28/2022
Device Age6 MO
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer11/18/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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