MAUDE Adverse Event Report: CONVATEC CURE PRODUCTS; CATHETER, URETHRAL

Model Number	M14C
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: 76 years, a3: male.(b)(6).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.Fda registration number, reporting site: 1049092 , manufacturing site: 3005471919.
Event or Problem Description
Consumer relayed he has had utis with use of the m14c, has used unknown qty, unknowm mus, unknown lots over the last 10 years, last one about a month ago.Consumer clarified he does not think these catheters do not cause his utis just that they occur periodically with use of them.He said he only told liberator (who reported it to us) of his recent uti as he said he wanted more qty of catheters per month as when he has these infections he will use 3 catheters per day instead of 2.He said he usually gets utis about once a year since he started cathing as an overall result from cathing and does not think it is the fault of these catheters.Not reporting them as defected in any way.This year he has had more utis - 2 separate utis " a couple months apart" last one being a month ago.His only uti symptom is the feeling of frequency/urgency.He will go to this pcp and get a urine test and then be treated with antibiotics for 14 days and his symptoms goes away.He said the last uti he reported per the urine testing was a "staph infection" in his urine and that was about a month ago.He was treated with antibiotics (name unknown) and symptoms resolved as they always do after treatment.He has not followed up with his urologist and was advised to do so.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 17880528
• Report Number: 1049092-2023-00287
• Device Sequence Number: 7760383
• Product Code: GBM
• UDI-Device Identifier: 00815947020086
• UDI-Public: 00815947020086
• 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): 10/04/2023

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: M14C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/05/2023
• 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