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

Catalog Number CUR9314

Patient Problem Chemical Exposure (2570)

Event Date 01/15/2024

Event Type  malfunction  

Event Description

Curad brand gloves tearing when donned.Caused skin exposure to formalin-soaked specimens and xylene.

• Brand Name: CURAD
• Type of Device: VINYL PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 18639473
• MDR Text Key: 334517468
• Report Number: 18639473
• Device Sequence Number: 1
• Product Code: LYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2024

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: Other
• Device Catalogue Number: CUR9314
• Device Lot Number: ME304009947
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2024
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1