MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC URINARY BAG; BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE

Lot Number 7552009

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 05/01/2021

Event Type  Injury  

Event Description

At night the bag kinks when it's full and the catheter stretches this causes it to collapse and urine to back up that causes pain.Reporter states he has made contact with manufacturer and is having problems with (b)(6) with reimbursement/replacements for the malfunctioning urinary leg bags and catheters.

• Brand Name: URINARY BAG
• Type of Device: BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC
• MDR Report Key: 13473332
• MDR Text Key: 285369325
• Report Number: MW5107260
• 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: Patient
• Type of Report: Initial
• Report Date: 02/04/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 7552009
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 98 KG