ORAL CARE KIT,W/MOIST,PEROXIDE 12260 991096883

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-02-03 for ORAL CARE KIT,W/MOIST,PEROXIDE 12260 991096883 manufactured by Halyard Health.

Event Text Entries

[66552212] The actual complaint product was not returned for evaluation. A review of the device history record is not possible as no lot number was provided. Root cause could not be determined. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the halyard health complaint database and identified as complaint (b)(4). Device not returned.
Patient Sequence No: 1, Text Type: N, H10


[66552213] Halyard received a single report that referenced an unknown number of incidences, which were associated with separate units, involving an unknown number of patients. Due to the unknown number of incidences, two reports will be submitted. This is the first of two reports. Refer to 8030647-2017-00012 for the second event. It was reported that a distributor experienced an unspecified number of oral swab sticks that broke during use. There was no known patient injury. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030647-2017-00005
MDR Report Key6301764
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2017-02-03
Date of Report2017-01-09
Date Mfgr Received2017-01-09
Date Added to Maude2017-02-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LISA CLARK
Manufacturer Street5405 WINDWARD PARKWAY
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4704485444
Manufacturer G1AVENT S DE RL DE CV
Manufacturer StreetCARRETERA INTERNACIONAL SALIDA NORTE NO. 1053
Manufacturer CityMAGDALENA, CP 84160
Manufacturer CountryMX
Manufacturer Postal Code84160
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORAL CARE KIT,W/MOIST,PEROXIDE
Generic NameVAP ORAL CARE PRODUCTS
Product CodeKXF
Date Received2017-02-03
Model Number12260
Catalog Number991096883
Lot NumberUNKNOWN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHALYARD HEALTH
Manufacturer Address5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
10 2017-02-03

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