DENTIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for DENTIPS manufactured by Productos Medline S.a. De C.v..

Event Text Entries

[128276318] Rn was opening a blue dentips disposable oral swab when the blue sponge became disconnected from the white stick, the nurse did not use it on this pt. It came apart when opening the packaging. In investigating this, it was discovered that the ticu has 2 different kinds of dentips blue swabs, some have a lot number, but the one in question that fell apart does not have a lot number anywhere on the packaging.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW5081545
MDR Report Key8095195
Date Received2018-11-20
Date of Report2018-11-19
Date of Event2018-11-12
Date Added to Maude2018-11-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameDENTIPS
Generic NameAPPLICATOR, ABSORBENT TIPPED, STERILE
Product CodeKXG
Date Received2018-11-20
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerPRODUCTOS MEDLINE S.A. DE C.V.
Manufacturer AddressONE MEDLINE PL MUNDELEIN IL 60060 US 60060

Device Sequence Number: 1

Brand NameDENTIPS
Generic NameAPPLICATOR, ABSORBENT TIPPED, STERILE
Product CodeKXG
Date Received2018-11-20
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPRODUCTS MEDLINE S.A. DE C.V.
Manufacturer AddressONE MEDLINE PL MUNDELEIN IL 60060 US 60060

Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-11-20
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