MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG

Catalog Number	150719
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an adverse skin dermatitis reaction to the contents in the bag around leg.Customer had a bad skin reaction after 3 to 4 days after placement on both legs.Two occurrences of this as each leg bag had this issue.Emergency room visited and steroids to lower inflammation.Customer wanted to know active ingredient in the bag as well had trends if this had occurred with other patients.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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 bd.
Event or Problem Description
It was reported that an adverse skin dermatitis reaction to the contents in the bag around leg.Customer had a bad skin reaction after 3 to 4 days after placement on both legs.Two occurrences of this as each leg bag had this issue.Emergency room visited and steroids to lower inflammation.Customer wanted to know active ingredient in the bag as well had trends if this had occurred with other patients.Per additional information received via phone on 30jan2025, stated that they did nit have a lot# for the leg bags and informed that the bags were made of vinyl.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No additional actions can be taken at this time since root cause was not identified.A dhr could not be performed since no lot number was provided.The instructions for use were found adequate and state the following: "directions for use: 1.Insert soft loop-pad end of strap through strap slits on leg bag, so that straps run behind bag, and loop-pad faces bag.2.Wrap straps around leg, either on thigh or calf.(if straps are too long, remove leg bag.Cut straps at separations between loop-pads, only, to achieve desired length.) 3.Locate leg bag on inside of leg and connect strap ends by pressing together.Straps must fit snugly, but must be comfortable.Washing instructions: do not use bleach.Wash in warm water." udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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 bd.

• Brand Name: LEG BAG
• Common Device Name: LEG BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21264800
• Report Number: 1018233-2025-00379
• Device Sequence Number: 9646699
• Product Code: FAQ
• UDI-Device Identifier: 00801741050855
• UDI-Public: (01)00801741050855
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 150719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown