MAUDE Adverse Event Report: COLOPLAST A/S MOVEEN NIGHT BAG,2000/140; BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE

Model Number 2135601400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, the end user had a bladder infection which was not treatable with normal antibiotics.A picc line had to be administered and a concoction of medicine was infused for seven days.Per notes, end user is currently using competitor foley from poieses duette indwelling catheters with our 21356 moveen drainage bag.

• Brand Name: MOVEEN NIGHT BAG,2000/140
• Type of Device: BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, region hovedstaden 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S TATABANYA; bùzavirág u. 15; tatabánya, 2800 ; HU 2800
• Manufacturer Contact: mike bumgarner ; 1601 west river road n; minneapolis, MN 55411 ; 6122630488
• MDR Report Key: 8061725
• MDR Text Key: 126922486
• Report Number: 3003814961-2018-00001
• Device Sequence Number: 0
• Product Code: FAQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2135601400
• Device Catalogue Number: 2135601400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR