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U.S. Department of Health and Human Services

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

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COLOPLAST A/S CONTINENCE CARE; FREEDOM CLEAR SS: PRODUCT CODE NNX Back to Search Results
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.
 
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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 Key10195704
MDR Text Key196447704
Report Number3006606901-2020-00008
Device Sequence Number1
Product Code NNX
Combination Product (y/n)N
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number5053111400
Device Catalogue Number5053111400
Device Lot Number6794369
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Initial Date Manufacturer Received 06/18/2020
Initial Date FDA Received06/25/2020
Supplement Dates Manufacturer Received07/30/2020
Supplement Dates FDA Received08/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age75 YR
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