MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. DENTIPS; APPLICATOR, ABSORBENT TIPPED, STERILE

Catalog Number MDS096011

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 03/17/2019

Event Type  malfunction  

Event Description

While performing routine mouth care, oral care swab/sponge separated from stick and remained in the patient's mouth.Sponge was recovered by bedside rn with 4th attempt at oral sweep.

• Brand Name: DENTIPS
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; three lakes drive; northfield IL 60093
• MDR Report Key: 8495069
• MDR Text Key: 141327432
• Report Number: 8495069
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 10888277116641
• UDI-Public: (01)10888277116641
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MDS096011
• Device Lot Number: 18-285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 930 DA