MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH CH14 FEMALE; INTERMITTENT CATHETER

Model Number	2851401400
Health Effect - Clinical Code	Urinary Tract Infection (2120)
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.However, a recheck of the product documentation for this lot number did not reveal any norm deviation that could be related to the complaint.Complaints such as this is a new issue with this product line.The complaints are monitored closely for a forming trend and reported to management on a monthly basis.Production has been informed.
Event or Problem Description
According to the available information, the daughter of end user called in and said her mom (the end user) got a uti and they thought it was due to the package having holes or punctures in it.Package was sealed, but they said there were holes in the package.The catheter was used at night so they did not notice the holes.

• Brand Name: SPEEDICATH CH14 FEMALE
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 6106479
• Report Number: 3006606901-2016-00043
• Device Sequence Number: 19002906
• Product Code: GBM
• UDI-Device Identifier: 05708932020527
• UDI-Public: 05708932020527
• Combination Product (Y/N): N
• PMA/510(K) Number: K023254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/16/2016

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 Expiration Date: 04/14/2018
• Device Model Number: 2851401400
• Device Catalogue Number: 2851401400
• Device Lot Number: 5120263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2016
• Initial Report FDA Received Date: 11/16/2016
• 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
• Patient Age: 60 YR