MAUDE Adverse Event Report: COLOPLAST A/S CONTINENCE CARE; FREEDOM CLEAR SS: PRODUCT CODE NNX

Model Number 5053111400

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The two other freedom clear ss catheters referenced in the case description were previously reported under mfr#'s 3006606901-2020-00006 and 3006606901-2020-00007.

Event Description

It was reported that after sample use of different sizes of freedom catheters by the patient (31 mm, 28 mm, and another 31 mm), the patient determined that the 31 mm size worked the best as the 28 mm was too tight.After removal of the last catheter from the penis, puss was observed coming out of the end of the penis.The patient was taken to the hospital where he was diagnosed with a possible e-coli infection.It is unknown if treatment was performed.It is unknown if the e-coli infection is device related; however, the patient remained in the hospital and was later transferred to a nursing home for a 2 week extended care stay.No further information was provided.

Manufacturer Narrative

Based on the results of the investigation, the reported event was found inconclusive as the problem could not be reproduced in the lab.Our manufacturing site is aware of this event and we have entered this complaint into our trending report that is reviewed by our management team.A review of the device history record did not indicate any manufacturing non-conformance that could have caused or contributed to the reported event.

• Brand Name: CONTINENCE CARE
• Type of Device: FREEDOM CLEAR SS: PRODUCT CODE NNX
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, region hovestaden; 3050, ; DA
• MDR Report Key: 10195704
• MDR Text Key: 196447704
• Report Number: 3006606901-2020-00008
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5053111400
• Device Catalogue Number: 5053111400
• Device Lot Number: 6794369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR