MAUDE Adverse Event Report: COLOPLAST A/S FREEDOM SELF-CATH NELATON CH18; INTERMITTENT CATHETER

Model Number	5045501400
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	12/12/2015
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 information received, end user says the holes do not appear to be punched correctly (not smooth around holes).Says the area around the holes are "bulged up" leaving the eyelets rough rather than smooth.Says he has been getting cut by the catheters as a result.He has had bleeding for a day, and then it subsides.
Additional Manufacturer Narrative
Samples (8) were received for evaluation.Eight (8) pcs with lot 4678381 received on 2016-01-12 and tested.Test result: all products were tested ok.A recheck of the product documentation for this lot number did not reveal any norm deviation that could be related to the complaint.Because the test result of the returned samples were ok, and (b)(4) was initiated to follow the rough eyelets issue, so complaint closed.
Event or Problem Description
End user received order of 418.He says the holes do not appear to be punched correctly (not smooth around holes).Says the area around the holes are "bulged up" leaving the eyelets rough rather than smooth.Says he has been getting cut by the catheters as a result.He has had bleeding for a day, and then it subsides.He says he has not needed additional medical attention because the problem seems to have corrected itself.

• Brand Name: FREEDOM SELF-CATH NELATON CH18
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 5352462
• Report Number: 2183558-2016-00001
• Device Sequence Number: 18902455
• Product Code: KOD
• UDI-Device Identifier: 05708932576383
• UDI-Public: 05708932576383
• 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: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Followup
• Report Date (Section B): 03/28/2016

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/20/2019
• Device Model Number: 5045501400
• Device Catalogue Number: 5045501400
• Device Lot Number: 4678381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2016
• Supplement Report FDA Received Date: 03/28/2016
• 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
• Patient Age: 64 YR