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

Model Number	ULTRA M14
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
Additional Manufacturer Narrative
A2: age: 65, sex: male; d2: common device name: catheter, urological; 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.Reporting site: 1049092; manufacturing site: 3005471919.
Event or Problem Description
End user states "he was used to using the magic 3 go catheters and those went on backorder.He is not new to cathing and has been cathing 3 x a day for about 1.5 yrs due to retention from an unknown cause.He has had multiple utis in the past even while cathing with his bard magic 3 go catheters.He was sent the ultram14 to use instead and had been using them for a little over a month ok but a few times, about "2 or 3 times" with these catheters he would note hurt with insertion and he would see blood at the tip of the catheter upon retraction.It was a small amount on on catheter tip and would stop immediately.He said the tips of those felt "too sharp on the end" compared to the others he had used and thinks they cut him inside urethra.He said the defect was visible after examination.He does not have them anymore, lots unavailable.He said shortly after this happened his urine started to smell very bad and then his symptoms progressed to a high fever ( could not relay how high), vomiting, diarrhea and pain.He was hospitalized and treated at bethesda hospital in ohio for 7 days, diagnosed with a uti and currently has been wearing a foley catheter for about a month now and has visit monday to follow up with urologist to decide if he needs to continue with foley or return to ic.He said he is feeling much better from his uti.He was sent home with oral antibiotics name unknown and he has already completed those.He does wash his hands with soap and water prior to cathing, uses the no touch sleeve and ensures catheter stays sterile prior to entry as well as always cleanses meatus with soap and water prior to insertion.".

• 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: 17133786
• Report Number: 1049092-2023-00173
• Device Sequence Number: 20445069
• Product Code: KOD
• UDI-Device Identifier: 00815947021069
• UDI-Public: 00815947021069
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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: ULTRA M14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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