MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS; CATHETER, STRAIGHT

Model Number	510811
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Skin Tears (2516)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mdr 1049092-2022-00287 / initial 2 of 2.Common device name - catheter, urological.Based on the available information, this event is deemed to be a serious injury.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: (b)(4).Manufacturing site: (b)(4).
Event or Problem Description
Consumer states "the catheters blue line was not printed straight down delineating the coude tip but rather it was twisted "like a candy cane" as well as some had a sharpness towards the end, by the eyelets which cased him tearing in his urethra, bleeding and resulted in a uti.He caths 3 x a day for retention due to an enlarged prostate and history of prostate cancer.He wasn't sure if some of the catheters that had the blue line that was printed twisted and not following the coude tip were also affected with the sharpness he felt at the tip at the the rough eyelets, he said they very well could have.When he placed the catheter with the wavy blue lines he noted it was uncomfortable going in as the tip twisted internally.After he noticed the blue line was not printed straight, he said he would make sure to hold it at the funnel end with the coude tip up and not follow the line.He said he is aware to place coude tip pointed upwards.He has cath'd for 7 years.He is always makes sure to wash his hands prior to cathing or sanitize his hands if water is not available and he always wipes his meatus prior to placing his catheters.He also is mindful to keep his catheter sterile and not touch the catheter itself when placing his urethra.He said he had bleeding about 5 times with sharpness noted near the tip, he said he thinks the eyelets were "jagged" and of these 3 of these catheters he had bleeding episodes with small "meat chunks" he is describing as urethral pieces stuck on the rough eyelets and inside the catheter as he retracted the catheters from his urethra.He said he could feel the sharpness as he got to his prostate area and this is where he thinks it scratched and tore him.He said when it bled it only bled a little bit and was only lightly tinged in his urine.He is not on blood thinners.He said because of the lubricant on the catheters, he could not notice this roughness prior visually.He said his urethra felt sensitive for about 5-6 days.Shortly after using these defected catheters he said he started to develop uti symptoms thinking they caused it.He had cloudy thick mucous like urine, general body aches and enlarged lymph nodes on his neck.He said he called his pcp and they just ordered him a lab test to check his urine.He went and did a urinalysis and urine culture and started him on an antibiotic which was changed to ampicillin after the urine culture came back final which he is still taking.He is feeling much better now." end user could not give provide exact total stating "maybe around several "up to 10" had the defects he is describing." this emdr is to capture the unknown quantity.
Additional Manufacturer Narrative
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
To date no additional patient or event details have been received.

• Brand Name: L3C0600 - CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• 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: 14461094
• Report Number: 1049092-2022-00287
• Device Sequence Number: 4722478
• Product Code: EZD
• UDI-Device Identifier: 00815947021090
• UDI-Public: 00815947021090
• Combination Product (Y/N): N
• Initial Reporter State: OK
• PMA/510(K) Number: K072539
• 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,Followup
• Report Date (Section B): 05/13/2022

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: 07/28/2024
• Device Model Number: 510811
• Device Lot Number: 210813-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2021
• 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