MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC FREEDOM SELF-CATH PED CH06 30; INTERMITTENT CATHETER

Model Number	5044101400
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2015
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
According to the information received, end users mom caths daughter with spina bifida for 5 months.She noticed nothing was coming out when cathing end user and thought she didn't have any residual.After pulling out cath realized there were no eyelets.

• Brand Name: FREEDOM SELF-CATH PED CH06 30
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• MDR Report Key: 5379505
• Report Number: 2183558-2016-00003
• Device Sequence Number: 10880468
• Product Code: KOD
• UDI-Device Identifier: 05708932575959
• UDI-Public: 05708932575959
• Combination Product (Y/N): N
• PMA/510(K) Number: K003784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Caregivers
• Report Date (Section B): 01/19/2016

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
• Operator of Device: Other Caregivers
• Device Expiration Date: 07/13/2019
• Device Model Number: 5044101400
• Device Catalogue Number: 5044101400
• Device Lot Number: 4464131
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 MO