MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH COMPACT CH12 FEMALE; INTERMITTENT CATHETER

Model Number	2858201400
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/30/2017
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 available information, end user said the catheter seems brittle and broke as she inserted it.Thinks that part of it may have broken off inside of her as she can't find the other part of it after she took it out.Has no pain, right now, but is worried about an infection - advised her to go see a doctor.She threw the catheter away.She is not 100% sure that the catheter is still inside her.She thinks that because she can't find the broken piece.All she kept saying was that the catheter broke in half.
Additional Manufacturer Narrative
This follow-up mdr was created to document additional information submitted by the end-user.Furthermore, no additional complaints registered about this lot number.The complaints are monitored closely for a forming trend and reported to management on a monthly basis.Production has been informed.There was no ncr for this lot.
Event or Problem Description
According to the additional information received, customer found that the catheter did not break off inside of her.What she found was that the catheter broke off and went into the packaging and said that if she twists it a certain way, then it breaks.She said that it wasn't the fault of the products.Just the way she twists the catheter and is going to be more careful.

• Brand Name: SPEEDICATH COMPACT CH12 FEMALE
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 6339883
• Report Number: 3006606901-2017-00006
• Device Sequence Number: 16262255
• Product Code: GBM
• UDI-Device Identifier: 05708932020565
• UDI-Public: 05708932020565
• 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
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017

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: 2858201400
• Device Catalogue Number: 2858201400
• Device Lot Number: 5113168
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 02/27/2017
• 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
• Patient Age: 58 YR