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

Model Number	2881401400
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	07/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was received for evaluation.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.A recheck of the product documentation for this lot number did not reveal any norm deviation that could be related to the complaint.However, the complaints are monitored closely for a forming trend and reported to management on a monthly basis.A corrective action is ongoing- where all relevant documentation about findings and actions are stated.
Event or Problem Description
According to the information received, product not extending all the way.End user stated that because she did not have any more catheters, she then tried to pull one out with her teeth and somehow damaged her teeth.She was not able to get the catheters to fully extend.I do not know the extent of the damage to her teeth.

• Brand Name: SPEEDICATH COMPACT PLUS CH14
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 5848356
• Report Number: 3006606901-2016-00027
• Device Sequence Number: 414524
• Product Code: GBM
• UDI-Device Identifier: 05708932020633
• UDI-Public: 05708932020633
• Combination Product (Y/N): N
• PMA/510(K) Number: K072808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/04/2016

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: Lay User/Patient
• Device Model Number: 2881401400
• Device Catalogue Number: 2881401400
• Device Lot Number: 4749450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2016
• Initial Report FDA Received Date: 08/04/2016
• 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