MAUDE Adverse Event Report: CONVATEC CURE PRODUCTS; CATHETER, UROLOGICAL

Model Number	ULTRA14
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 35 of 50.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number, reporting site: 1049092, manufacturing site: 3005471919.
Event or Problem Description
End user reports that individual catheter packaging wrappers have holes/ scrapes/ areas that look melted on them.She decided to report this product defect to us today as she said she kept finding so many with the issue.She said from 3 mu boxes all of same reported lot, she has found 50 catheters where the individual catheter packaging wrapper has what looks like small holes/ scrapes/ some areas that appear melted on the packaging exposing parts of the catheter underneath.She said in some areas this does expose parts of the clear plastic part of the catheter, not so much near the funnel end.She said not every catheter affected from these 3 mu boxes, but stated 50 were like this from those 3 mu boxes.She said the ultra boxes they came from look undamaged, the primary shipping box also undamaged.She said she keeps them in a room temperature environment and said there is no way they could have gotten damaged at her house and that they looked like this when you remove them from the ultra14 mu boxes.She used 20 so far to cath with stating the catheter itself was still ok, no concerns with use but she did throw away and not use 30 of them.No harm from use she reports.
Additional Manufacturer Narrative
Device 35 of 50 this complaint has been evaluated, an investigation was completed by a third party supplier.Retained samples from the complained lots were reviewed by the supplier and no abnormity found.From the investigation result, ¿the defects happen to the bottom film.Normally, if the film itself have such defect before blister, it can not form the cavity correctly, and our worker can find it.So we believe it happened after blister packing.And after blister packing, we have 100% visual inspection to the products before putting into box.We checked on the production line, there is no possiblity to cause such defect, and we haven't seen similar defect on line.So we can't tell the root cause.No action to take for now.¿ this investigation will be closed.This issue will be monitored through the post market product monitoring review process, sop-000741.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 3005471919.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 20952164
• Report Number: 1049092-2024-00192
• Device Sequence Number: 20729145
• Product Code: KOD
• UDI-Device Identifier: 00815947020444
• UDI-Public: 00815947020444
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K221593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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 Expiration Date: 09/28/2026
• Device Model Number: ULTRA14
• Device Lot Number: 23B15706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female