MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. SENSICARE; SURGEON'S GLOVES

Lot Number 1122659070-3

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2023

Event Type  malfunction  

Event Description

When sterile box of medline sensicare size 7 gloves was opened, healthcare providers found a metal-bolt-like object inside sterile packaging.

• Brand Name: SENSICARE
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 17057588
• MDR Text Key: 316491175
• Report Number: 17057588
• Device Sequence Number: 1
• Product Code: KGO
• 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: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 1122659070-3
• 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: 05/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1