MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; ORAL CARE SWAB / APPLICATOR ABSORBED / TIPPED STERILE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/28/2018

Event Type  malfunction  

Event Description

While performing oral care on patient using the ¿chg 0.12%.Oral rinse oral care kit¿ when the sponge part of the swab got disconnected from the plastic suction handle.Patient was sleepy and was not resisting my oral care.I was cleaning his tongue when suddenly the sponge disconnected spontaneously.I managed to scoop the sponge from the patient¿s mouth.

• Brand Name: MEDLINE
• Type of Device: ORAL CARE SWAB / APPLICATOR ABSORBED / TIPPED STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; mundelein IL 60060
• MDR Report Key: 7929912
• MDR Text Key: 122803393
• Report Number: MW5080305
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 10888277318625
• UDI-Public: (01)10888277318625
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2018

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: Health Professional
• Device Expiration Date: 02/28/2020
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR