MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP EXAM GLOVES; PATIENT EXAMINATION GLOVE, SPECIALTY

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

Upon entering the patient room, i grabbed 2 medium gloves from a nearly new box of gloves.(the gloves were obviously not used as they were flat and crinkled.) i slid the glove onto my left hand and immediately felt that there was a foreign object in 2 of the fingers of the gloves.I peeled off the glove to find a dry crumbly brown substance in the fingertips of the gloves.Upon inspection of my finger, i found the brown substance from the glove under my fingernail.I then collected the glove in a bag and removed the box of gloves from the patient room and reported it to the unit manager.

• Brand Name: EXAM GLOVES
• Type of Device: PATIENT EXAMINATION GLOVE, SPECIALTY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 1 medline place; mundelein IL 60060
• MDR Report Key: 14073600
• MDR Text Key: 288993093
• Report Number: 14073600
• Device Sequence Number: 1
• Product Code: LZC
• 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: 01/06/2022,11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1