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

Model Number	T16
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2a: common device name: catheter, urological.E1: sex: female, age: 76.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: 1049092 , manufacturing site: 3005471919.
Event or Problem Description
End user states "she feels like her last shipment of catheters (she gets 600 per 3 months) she has ¿opened a lot of them (boxes)¿ has still has multiple boxes at home and tried a few from each all of same lot #, and they all seem to lack the amount lubrication she was used to with this catheter.She said they were not exposed to any heat in her home.She said they seem like they are more ¿like little dried bumps¿ of lubrication.She said the gel is not enough as they used to be.She has used this catheter before and this was her usual catheter.She said then bought ky jelly to add to them since these seemed drier to be able to use them.She said she ¿runs them under water¿ and then lubricates it with the ky jelly with her finger.She said before she applies the ky jelly to her fingers to place on the catheter, she makes sure to wash her hands and use a castille soap wipe on her fingers too." end user was advised her to stop doing this and explained this contaminates the catheter and can place her at risk for utis as well.End user states "she always cleanses her urethra with a castille soap wipe as well prior to insertion.She said shortly after using this new batch of catheter and applying that extra ky jelly - after about 3 weeks of use, she thinks they caused her a utis, she states 2 utis, but she clarified that she had a (one) urine culture and was prescribed antibiotics then was switched to a stronger antibiotic for 7 days so it could have possibly been 1 uti that was difficult to clear from what i was able to gather.She knew she had a uti as she was having mainly strong odor, cloudy urine, dark colored urine.She said she gets utis often due to her neobladder and cathing in general but said she thought this last uti was from these catheters.She wasn¿t sure if she had light bleeding with these catheters upon retraction as she mentioned it but then said she wasn¿t sure as her urine was so dark it could have been that too and not blood.She also mentioned, she recently was prescribed estrogen cream she just started about 2 weeks ago applying due to the dryness and swelling she has in her genital area related to age related changes too as she is a 76 year old female.".

• 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: 16867287
• Report Number: 1049092-2023-00060
• Device Sequence Number: 5385872
• Product Code: KOD
• UDI-Device Identifier: 00815947020406
• UDI-Public: 00815947020406
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 04/13/2023

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: T16
• Device Lot Number: 220428-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2022
• 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: Unknown