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

Model Number	5046801400
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
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.In addition, a recheck of the product documentation for this lot number did not reveal any norm deviation that could be related to the complaint.
Event or Problem Description
According to the available information, the patient complaint regarding item# 614 - lot# 5607497 and 5865261.The patient stated that the catheters are causing him to bleed.The patient stated that hospitalization was required.The catheters may have been nicking a blood vessel in the prostate.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device.A capa was initiated to follow this case.370 samples were received and inspected.No anomalies were noted and no additional complaints were filed on lot number 5865261.The product documentation for this lot number did not reveal any norm deviation that could be related to the complaint.

• Brand Name: FREEDOM S-C TIE TAPERTIP CH14
• Common Device Name: CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7285652
• Report Number: 3005945907-2018-00002
• Device Sequence Number: 1210558
• Product Code: KOD
• UDI-Device Identifier: 05708932999441
• UDI-Public: 05708932999441
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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: 5046801400
• Device Catalogue Number: 5046801400
• Device Lot Number: 5865261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/12/2018
• 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