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

Model Number	510814
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
End user reports unknown number of ultramm14 catheters, unknown qty, unknown number of market units with unknown lot numbers of the same catheter over the last "couple shipments" that he feels upon insertion that have little to no lubricant which causes light bleeding and possibly contributing to recent recurring utis." he relayed "in his last few shipments he has noticed "a lot" but not all of these catheters had little lubricant to some "not having any." he said he has vision difficulties and so he cannot see it but rather feels it.When he tried to use them he said they "would get stuck on his skin" and he further clarified he meant they would get stuck in his urethra as they lacked sufficient lubrication compared to these catheters he had used in the past in prior shipments.He does not force them but removes and applies additional lube to make them work.He also has noticed some bleeding starting in the "last few weeks." he can see post cath when he dabs meatus with a gauze light drops of blood that stop quickly, only occurs maybe "1 out of every 100" times he felt catheters were dry catheters he used initially and then he had to remove to apply more lubricant to.He last had this occur this weekend.He is not taking blood thinners.Again, he bought additional lubricant to add to them to make these work and this helps a lot when he starts to feel the dryness as soon as he inserts.He also mentions he is in the middle of antibiotic treatment, levaquin, for a uti.He is not sure if the dry catheters are contributing to his utis.He said they have been recurrent lately and as soon as he is done with 1 course of antibiotics about a week and a half goes by and symptoms start again.He did go to his pcp and did urine testing which showed a uti.He said he gets them often and has pain, urgency and states he thinks a "mental element which affects his thinking" is also to blame for his utis".He said "he is diligent to wash his hands, wash his penis and then wash his hands again and keeps catheter sterile prior to insertion.He applies the additional lubricant to the tip of his penis and catheter directly trying to keep it as sterile as possible.He has no history of constipation nor any history of kidney or bladder stones.He said he has used these catheters for a long time since last october when he first started cathing and is cathing currently 5 x a day now for retention from bladder dysfunction." end user was advised if this recurrent uti keeps occurring as well as his bleeding he needs to follow-up with urologist.He said they are about 1.5 hrs away, hard for him to get to and he last visited about 2 months ago.This emdr is to address the uti's with unknown lot and market unit.
Additional Manufacturer Narrative
Device 2 of 2.Common device name: ultramm14 16 in straight tip.Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15510743
• Report Number: 1049092-2022-00375
• Device Sequence Number: 14932702
• Product Code: KOD
• UDI-Device Identifier: 00815947021069
• UDI-Public: 00815947021069
• Combination Product (Y/N): N
• PMA/510(K) Number: K080881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

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: 04/28/2025
• Device Model Number: 510814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2022
• 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 Sex: Male