MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE COTTON TIP APPLICATORS; APPLICATOR, ABSORBENT TIPPED, STERILE

Catalog Number MDS202010Z

Device Problems Incomplete or Missing Packaging (2312); Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 12/08/2015

Event Type  malfunction  

Event Description

Only 9 instead of 10 countable applicators were in the package when opened.

• Brand Name: MEDLINE COTTON TIP APPLICATORS
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 5276615
• MDR Text Key: 32986166
• Report Number: 5276615
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MDS202010Z
• Device Lot Number: 01015020001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2015
• 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
• Treatment: N/A.
• Patient Age: 45 YR
• Patient Weight: 64