MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. DENTIPS; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Lot Number 126737

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/28/2020

Event Type  malfunction  

Event Description

During mouth care 1 pint size dentip was discovered to be loose with top blue swab able to easily detach from stick.Event was discovered before reaching patient and swab was thrown away.

Event Description

During mouth care 1 pint size dentip was discovered to be loose with top blue swab able to easily detach from stick.Event was discovered before reaching patient and swab was thrown away.

• Brand Name: DENTIPS
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 10958238
• MDR Text Key: 219883581
• Report Number: 10958238
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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: No Information
• Device Lot Number: 126737
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1