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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUFFY'S GLOVES; VINYL PATIENT EXAMINATION GLOVE
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TUFFY'S GLOVES; VINYL PATIENT EXAMINATION GLOVE Back to Search Results
Device Problem Device Contamination with Body Fluid (2317)
Patient Problem No Patient Involvement (2645)
Event Date 07/28/2020
Event Type  malfunction  
Event Description
I purchase gloves from online (b)(6), the name of the product is tuffy's.This item came with blood inside it, imagine that.I bought it for protection and it came with blood all over the gloves.I will have a criminal case against your company regarding this issue; that is unacceptable.How you could send used gloves full of blood? i don't understand how (b)(6) doesn't have quality controller their online products?.
 
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Brand Name
TUFFY'S GLOVES
Type of Device
VINYL PATIENT EXAMINATION GLOVE
MDR Report Key10349599
MDR Text Key201398322
Report NumberMW5095811
Device Sequence Number1
Product Code LYZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/30/2020
Type of Device Usage N
Patient Sequence Number1
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