MAUDE Adverse Event Report: COLOPLAST A/S FREEDOM S-C TIE OLIVETIP CH14; INTERMITTENT CATHETER

Model Number	5047401400
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
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 damaged product.End-user does not think that any of the catheter remains in him.Appearance of a crack in the catheter near the bend and a barb like projection making the withdrawal painful.The bleeding has subsided and has a doctor's appointment next month.Advised to seek medical attention immediately if any further issues arise and he has agreed.
Additional Manufacturer Narrative
No products were received for testing.No additional complaints registered regarding this lot no.4926535.Capa (b)(4) was initiated on (b)(6) 2016 to follow this issue, so complaint closed now.

• Brand Name: FREEDOM S-C TIE OLIVETIP CH14
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 5870179
• Report Number: 3005945907-2016-00005
• Device Sequence Number: 1172554
• Product Code: KOD
• UDI-Device Identifier: 05708932999670
• UDI-Public: 05708932999670
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2016

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 5047401400
• Device Catalogue Number: 5047401400
• Device Lot Number: 4926535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2016
• Supplement Report FDA Received Date: 09/09/2016
• 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