401 DENTAL NDL 30SH 8881401072

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-05-23 for 401 DENTAL NDL 30SH 8881401072 manufactured by Covidien.

Event Text Entries

[147727619] The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10


[147727620] The customer reported the needles come off when taking the cap off. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1017768-2019-00644
MDR Report Key8637355
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-05-23
Date of Report2019-09-30
Date of Event2019-05-16
Date Mfgr Received2019-05-16
Date Added to Maude2019-05-23
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524970
Manufacturer G1COVIDIEN
Manufacturer Street2010 EAST INTERNATIONAL SPEEDW
Manufacturer CityDELAND FL 32724
Manufacturer CountryUS
Manufacturer Postal Code32724
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name401 DENTAL NDL 30SH
Generic NameNEEDLE, DENTAL
Product CodeDZM
Date Received2019-05-23
Model Number8881401072
Catalog Number8881401072
Lot Number903518
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2010 EAST INTERNATIONAL SPEEDW DELAND FL 32724 US 32724


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-23

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