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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOPKINS UNIFORM COMPANY HOPKINS MEDICAL PRODUCTS® SANI-CLOTH BLEACH DISINFECTANT, MEDICAL DEVICES

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HOPKINS UNIFORM COMPANY HOPKINS MEDICAL PRODUCTS® SANI-CLOTH BLEACH DISINFECTANT, MEDICAL DEVICES Back to Search Results
Model Number 692965
Device Problem Material Too Rigid or Stiff (1544)
Patient Problems Pain (1994); Swelling (2091)
Event Date 04/24/2019
Event Type  malfunction  
Event Description
Multiple staff with their finger stuck into opening of lid to thread wipes and fingers have been pinched and difficult to remove from lid. Design is not user friendly. While pushing new bleach wipe through teeth, staff finger was stuck. As staff was trying to pull finger out, the rigid teeth pressed deeply into finger, causing some swelling and pain. Another staff member had to assist with removal by cutting the teeth with scissors to prevent further injury. Multiple staff concern for the teeth on the lid as very rigid and sharp.
 
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Brand NameHOPKINS MEDICAL PRODUCTS® SANI-CLOTH BLEACH
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
HOPKINS UNIFORM COMPANY
6850 southbelt drive
caledonia MI 49316
MDR Report Key8657827
MDR Text Key146636594
Report Number8657827
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number692965
Device Catalogue Number692965
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/22/2019
Event Location Hospital
Date Report to Manufacturer05/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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