MAUDE Adverse Event Report: COLOPLAST A/S FREEDOM SELF-CATH NELATON CH12; CATHETER

Model Number	5045201400
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Injury (2348)
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 tot he available information, patient is stating that the catheter was bunching up in his urethra.Patient went to the hospital and they put him in a permanent catheter.Patient also stated that he has trauma to urethra and a lot of bleeding.End user also said that when he was having a bowel movement earlier today and when he strained blood came out of the catheter.He said he bled for 45 minutes.Eu stated that the doctor said that the inside track has been torn badly.No uti.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned samples: 264 samples received on (b)(6) 2017 and inspected - inspected result: ok.Because only 1 complaint registered on this lot number and the test result of the returned samples were ok, we have initiated (b)(4) to follow this case, so we decide continue to monitor the trends closely, and actions can be taken based on the trends.A recheck of the product documentation for this lot number did not reveal any norm deviation that could be related to the complaint.

• Brand Name: FREEDOM SELF-CATH NELATON CH12
• Common Device Name: CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 6941872
• Report Number: 3005945907-2017-00002
• Device Sequence Number: 795464
• Product Code: KOD
• UDI-Device Identifier: 05708932576314
• UDI-Public: 05708932576314
• 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: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: 5045201400
• Device Catalogue Number: 5045201400
• Device Lot Number: 5317131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 11/28/2017
• 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