UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-10 for UNK manufactured by Applied Medical Resources.

Event Text Entries

[134413861] No product is being returned for evaluation and no lot # has been provided to manufacturer. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10


[134413862] Procedure performed: unk. Limited information available at this time. Rep heard this information from a surgeon who had heard it from a tech that was in a case with another surgeon. Rep is trying to obtain more information. Ripped green coating off scissors to get it to fit into the 5mm trocar. Additional information received via email on 11dec2018 from applied medical account manager: i have been able to get the surgeons name but no other information yet. The or manager is planning to speak to the surgeon tmrw. Additional information was received via telephone on 26dec2018 11:01am from applied medical account manager: the model of the device would be either the cb030 or cb040. The rep has made multiple attempts via email and in person and no further information is available. The surgeon had trouble getting the scissors into the trocar. The surgeon that originally spoke with the account manager did not know the name of the tech nor the name of the surgeon involved in the case. Patient status: no patient injury reported. Type of intervention: unk.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027111-2019-00315
MDR Report Key8234059
Date Received2019-01-10
Date of Report2019-03-20
Date Mfgr Received2018-11-28
Date Added to Maude2019-01-10
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 ContactWENDY KOBAYASHI
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer CountryUS
Manufacturer Postal92688
Manufacturer Phone9497138059
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameUNK
Generic NameUNK
Product CodeHET
Date Received2019-01-10
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAPPLIED MEDICAL RESOURCES
Manufacturer Address22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-10

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