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

Model Number	ULTRA M14
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
End user reports recent pain & uti with unknown number of ultram14 catheters.End user states lately "he has had pain especially with insertion and retraction of this catheter only recently last few weeks noting small amount of blood at tip of catheter at retraction often.Bleeding is light and stops quickly without intervention.Pain however lasts.He has had pain with catheter use for last few weeks right around the time he was diagnosed with a uti as well.He said when he started having pain in bladder he had a urine sample done and his md said he had a uti to which he was prescribed 7 days of 500mg pills (name unknown) he had to take which helped his pain a little but but as soon as he finished the course his symptoms of greater pain returned.He said he has pain in his bladder as well as testicle last few weeks.He said he only has 1 testicle as in in the remote past one needed to be removed as it was infected due to a complication of chlamydia.He said he is still this pain and just took a tylenol to help with the pain." he said he was supposed to have cystoscopy on dec 1st due to this recent pain and recent uti but because he could not get a ride to his urologist he could not go.He has another appointment with md set up for tomorrow morning.He feels no resistance or blockages at all with use of these catheters.He has been using these catheters in the size 14fr for a very long time.He does not think his pain or uti is caused by the catheter itself ratheter, not claimng any defects, he thinks it is related to something changed internally or his uti and he agrees his technique for cic could improve to be cleaner to prevent utis.He has been cathing for many years due to retention as his bladder muscle doesn't work anymore he said.Mds are monitoring his psa as it is slightly elevated.He caths 3-4 times a day.He wears gloves when cathing but does not wash hands prior to cathing or putting on gloves.I stressed the importance of hand washing.He also does not cleanse meatus consistently prior to cathing as he said he will cath after a shower but that does not account for all the times he has to cath.I advised him to check with his urologist about wipes/ recommendations for this.He takes care to not touch the catheter and uses the no touch sleeve to insert.
Additional Manufacturer Narrative
Common device name: catheter, urological.Complainant street address: (b)(6).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).

• 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: 16025459
• Report Number: 1049092-2022-00547
• Device Sequence Number: 12169664
• 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): 12/08/2022

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: 03/28/2025
• Device Model Number: ULTRA M14
• Device Lot Number: 220412-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/21/2022
• 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: Male