ROCHESTER LEG BAG MED 48CS (12BX/CS) 49165

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-21 for ROCHESTER LEG BAG MED 48CS (12BX/CS) 49165 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[75816778] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[75816779] It was reported that the urine sits at the tip of the tube and does not always drain into the bag.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2017-02561
MDR Report Key6580808
Date Received2017-05-21
Date of Report2017-09-03
Date Mfgr Received2017-08-31
Date Added to Maude2017-05-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAMY GRAVLEY
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD PARQUE INDUSTRIAL AEROPUERTO
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameROCHESTER LEG BAG MED 48CS (12BX/CS)
Generic NameMALE EXTERNAL CATHETER
Product CodeFAQ
Date Received2017-05-21
Catalog Number49165
Lot NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD PARQUE INDUSTRIAL AEROPUERTO COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-21

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