MAUDE Adverse Event Report: COLOPLAST A/S SC FEMALE W/LUER END 14FR; INTERMITTENT CATHETER

Model Number	5019601400
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2016
Type of Reportable Event	Serious Injury
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 available information, end user had a 240 catheter surgically removed after she wasn't able to remove it from her urethra.Has multiple boxes left, but main catheter came from lot # 4114033.Unknown if catheter didn't meet usual length specifications, or whether this was a usage error (inserting catheter too far).
Additional Manufacturer Narrative
This follow-up mdr is created to document additional information in describe event or problem.Furthermore, we have initiated capa (b)(4) to follow this case, more investigations and actions please find in it.
Event or Problem Description
Was the user hospitalized for more than 24 hrs/overnight admission to get the catheter surgically removed? yes, she was in the hospital for about a day.Besides having the catheter stuck was the user harmed in any way? pain, bleeding etc.? she couldn't urinate while the catheter was stuck.What was the indication for use? no specific reason to use 240, didn't receive instruction from her physician, but received a little instruction.Is the it a first time user? she has been cathing for 15 years, but has been using the 240 for about a year but has used 214 previously.What is the outcome? was in the hospital for a day after her surgery, then had a foley catheter for about two weeks, and went back to intermittent catheters.*eu is a paraplegic.

• Brand Name: SC FEMALE W/LUER END 14FR
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 6291042
• Report Number: 3005945907-2017-00001
• Device Sequence Number: 11038609
• Product Code: KOD
• UDI-Device Identifier: 05708932575690
• UDI-Public: 05708932575690
• Combination Product (Y/N): N
• PMA/510(K) Number: K100878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: 5019601400
• Device Catalogue Number: 5019601400
• Device Lot Number: 4114033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other