MAUDE Adverse Event Report: MEDLINE CURAD; VINYL PATIENT EXAMINATION GLOVE

Model Number CUR9225

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2017

Event Type  malfunction  

Event Description

Curad non-sterile vinyl gloves have been ripping when staff don them as personal protective equipment.

Event Description

Curad non-sterile vinyl gloves have been ripping when staff don't them as personal protective equipment.The hospital believes the gloves has been discontinued by the manufacturer.

• Brand Name: CURAD
• Type of Device: VINYL PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): MEDLINE; one medline pl.; mundelein IL 60060
• MDR Report Key: 6600794
• MDR Text Key: 76289512
• Report Number: 6600794
• Device Sequence Number: 1
• Product Code: LYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

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
• Device Model Number: CUR9225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1