MAUDE Adverse Event Report: HOLLISTER INCORPORATED HOLLISTER LEG URINE BAG; BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE

Model Number 1D126

Device Problems Defective Component (2292); Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 10/22/2021

Event Type  Injury  

Event Description

Patient was given a urine leg bag to wear and the bag was defective and sealed, it would not allow urine to drain into the bag.Fda safety report id# (b)(4).

• Brand Name: HOLLISTER LEG URINE BAG
• Type of Device: BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 12780553
• MDR Text Key: 280609855
• Report Number: MW5105209
• Device Sequence Number: 1
• Product Code: NNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1D126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White