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

Lot Number MDS096504

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/14/2021

Event Type  malfunction  

Event Description

While nurse was completing oral care with foam swab, patient bit end of foam swab off, swab was retrieved by nurse and remainder of swabs were removed from room, not to be used with this patient.Fda safety report id# (b)(4).

• Brand Name: DENTIFRICE
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 12087947
• MDR Text Key: 259223722
• Report Number: MW5102199
• Device Sequence Number: 1
• Product Code: KXF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/25/2021

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: MDS096504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR