5MM X 32CM PROBE AND VALVE C6001 100637601

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2009-08-11 for 5MM X 32CM PROBE AND VALVE C6001 100637601 manufactured by Applied Medical Resources.

Event Text Entries

[1109049] "the suction was blocked while operating in surgery. There are four suctions that show the same problem. But customer has already abandoned it, and only had two wrapping bags left. "
Patient Sequence No: 1, Text Type: D, B5


[8293593] Upon receipt and evaluation of the incident device, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2027111-2009-00077
MDR Report Key1448946
Report Source06,08
Date Received2009-08-11
Date of Report2009-08-11
Date of Event2009-07-30
Date Facility Aware2009-07-30
Report Date2009-08-11
Date Reported to Mfgr2009-07-30
Date Mfgr Received2009-07-30
Date Added to Maude2009-10-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactJAN RANK
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer CountryUS
Manufacturer Postal92688
Manufacturer Phone9497138237
Manufacturer G1APPLIED MEDICAL RESOURCES
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer Postal Code92688
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name5MM X 32CM PROBE AND VALVE
Generic NameSUCTION IRRIGATOR
Product CodeFHF
Date Received2009-08-11
Model NumberC6001
Catalog Number100637601
Lot Number1082232
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAPPLIED MEDICAL RESOURCES
Manufacturer AddressRANCHO SANTA MARGARITA CA


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2009-08-11

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