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

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.

• Brand Name: HOPKINS MEDICAL PRODUCTS® SANI-CLOTH BLEACH
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): HOPKINS UNIFORM COMPANY; 6850 southbelt drive; caledonia MI 49316
• MDR Report Key: 8657827
• MDR Text Key: 146636594
• Report Number: 8657827
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 10310819001318
• UDI-Public: (01)10310819001318
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 692965
• Device Catalogue Number: 692965
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1