PROD TEST BRAND M12345 C12345

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,literature,study,use report with the FDA on 2015-08-08 for PROD TEST BRAND M12345 C12345 manufactured by Abbott Diabetes Care Inc..

Event Text Entries

[22370867] Adding text at point of redaction - then redacting.
Patient Sequence No: 1, Text Type: N, H10


[22370868] Redacting in prod
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2954323-2015-11111
MDR Report Key4987491
Report SourceCONSUMER,LITERATURE,STUDY,USE
Date Received2015-08-08
Date of Report2015-08-08
Date of Event2015-08-08
Date Facility Aware2014-08-08
Report Date2015-08-08
Date Reported to FDA2015-08-01
Date Reported to Mfgr2015-08-01
Date Added to Maude2015-08-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. VAIBHAV PRADHAN
Manufacturer Street1360 SOUTH LOOP RD.
Manufacturer CityALAMEDA CA 94502
Manufacturer CountryUS
Manufacturer Postal94502
Manufacturer G1ABBOTT DIABETES CARE INC.
Manufacturer Street1360 SOUTH LOOP RD.
Manufacturer CityALAMEDA CA 94502
Manufacturer CountryUS
Manufacturer Postal Code94502
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROD TEST BRAND
Generic NamePROD DEVICE TYOE
Product CodeDFD
Date Received2015-08-08
Model NumberM12345
Catalog NumberC12345
Lot NumberL12345
ID NumberO12345
Device Expiration Date2016-01-01
OperatorNO INFORMATION
Device Availability*
Device Age15 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT DIABETES CARE INC.
Manufacturer Address1360 SOUTH LOOP RD. 1006 ALAMEDA CA 94502 US 94502


Patients

Patient NumberTreatmentOutcomeDate
101. Congenital Not Applicablenomaly; 2. Life Threatening 2015-08-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.