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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; PATIENT EXAMINATION GLOVE
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; PATIENT EXAMINATION GLOVE Back to Search Results
Device Problems Crack (1135); Material Integrity Problem (2978); Device Fell (4014)
Patient Problem Insufficient Information (4580)
Event Date 06/01/2021
Event Type  malfunction  
Event Description
A cracked bag of product that was dropped due to size and functionality of the gloves resulted in patient being treated with antibiotics.
 
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Type of Device
PATIENT EXAMINATION GLOVE
MDR Report Key12009511
MDR Text Key256732035
Report Number12009511
Device Sequence Number1
Product Code FMC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2021
Date Report to Manufacturer06/14/2021
Type of Device Usage Unknown
Patient Sequence Number1
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