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 2017-07-25 for BARD DISPOZ-A-BAG LEG BAG UNK manufactured by Productos Para El Cuidado De La Salud -9611590.

Event Text Entries

[81140809] 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: " directions for use: 1. Separate notches within circles. Pull straps through holes and around leg. 2. Position bag on leg with flutter valve at top. 3. Attach catheter or extension tubing to top inlet. When wearing bag below knee, attach bard extension tubing (catalog no. 150615 or 4a4194). When using extension tubing, make sure to connect tube at least to the 3rd taper of the connector. 4. To empty dispoz-a-bag, push green lever on flip-flo valve out and down. Important: be sure to reclose flip-flo valve after emptying bag. " (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


[81140810] It was reported that urine would not drain into the drain bag, until the patient realized that the extension tube needed to be trimmed. The complainant complained that the instructions are "not good for first time users".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2017-03958
MDR Report Key6742848
Date Received2017-07-25
Date of Report2017-07-25
Date Mfgr Received2017-07-10
Date Added to Maude2017-07-25
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 Received2017-07-25
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2017-07-25

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