BARD DISPOZ-A-BAG LEG BAG UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-06 for BARD DISPOZ-A-BAG LEG BAG UNK manufactured by Productos Para El Cuidado De La Salud -9611590.

Event Text Entries

[76861528] 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


[76861529] It was reported that the patient was allegedly having issues getting urine to drain into the leg bag. He was advised, by ms&s, that the issue could be due to the air lock. He described how the bag was not vented like the overnight bag. The front and back of the bag had to be pulled apart to get air into the tubing. He was advised that when using a male external catheter, the tubing should be kept straight to keep the urine from backing up into the tubing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2017-02978
MDR Report Key6616372
Date Received2017-06-06
Date of Report2017-08-09
Date Mfgr Received2017-07-19
Date Added to Maude2017-06-06
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 G1PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
Manufacturer StreetKM. 7 CARRETERA INTERNACIONAL
Manufacturer CityNOGALES, SONORA 85621
Manufacturer CountryMX
Manufacturer Postal Code85621
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBARD DISPOZ-A-BAG LEG BAG
Generic NameLEG BAG
Product CodeFAQ
Date Received2017-06-06
Catalog NumberUNK
Lot NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
Manufacturer AddressKM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA 85621 MX 85621


Patients

Patient NumberTreatmentOutcomeDate
10 2017-06-06

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