BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE, FABRIC STRAPS, 150732

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2017-03-31 for BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE, FABRIC STRAPS, 150732 manufactured by Productos Para El Cuidado De La Salud -9611590.

Event Text Entries

[71391433] 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


[71391434] It was reported that the drain bag was leaking from the seams around the drain valve. The patient allegedly experienced a uti that was treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5


[74722849] The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use states the following: "3. Malfunction and adverse events: - catheter kinking, damage, rupture. - difficulty or failure to remove the device. - occlusion of catheter inner lumens. - encrustation. - accidental removal of the device due to leakage of sterile water or balloon rupture. - device damage due to inappropriate use. - failure to measure temperatures. - improper temperature indication. 2) adverse events: - urinary-tract infection. - hemorrhage, hematuria. - allergy reaction to the device. - calculus formation. - edema. - pain. - discomfort. - injury of bladder or urethral. - urethritis, urinary incontinence. - retained balloon fragments. " (b)(4). 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


[74722850] It was reported that the drain bag was leaking from the seams around the drain valve. The patient allegedly experienced a uti that was treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2017-01466
MDR Report Key6449082
Report SourceCONSUMER,OTHER
Date Received2017-03-31
Date of Report2017-05-03
Date Mfgr Received2017-04-13
Date Added to Maude2017-03-31
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 Report3

Device Details

Brand NameBARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE, FABRIC STRAPS,
Generic NameDRAIN BAG
Product CodeFAQ
Date Received2017-03-31
Catalog Number150732
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
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
101. Required No Informationntervention 2017-03-31

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