MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS

Model Number	510852
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120); Genital Bleeding (4507)
Type of Reportable Event	Serious Injury
Event or Problem Description
Product end user reports difficulty with insertion of catheter.The end user states he has been catheterizing for 14 years.He reports he began to develop fevers as high as 102.5 and felt achy and had blood clots and tissue coming from his catheters.He states he went to md who obtained urinalysis with culture and sensitivity, he began taking a prescription of sulfa that was ordered for another issue.The results came back and he was diagnosed with uti with e.Coli and macrobid oral course was ordered.No photograph depicting the reported complaint issue was received.
Additional Manufacturer Narrative
Device 1 of 1.Common device name: cure catheter® for men.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).
Additional Manufacturer Narrative
Device 1 of 1.Common device name: cure catheter® for men.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
Product end user reports difficulty with insertion of catheter.The end user states he has been catheterizing for 14 years.He reports he began to develop fevers as high as 102.5 and felt achy and had blood clots and tissue coming from his catheters.He states he went to md who obtained urinalysis with culture and sensitivity, he began taking a prescription of sulfa that was ordered for another issue.The results came back and he was diagnosed with uti with e.Coli and macrobid oral course was ordered.No photograph depicting the reported complaint issue was received.

• Brand Name: L3C0600 - CURE PRODUCTS
• 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: 13208634
• Report Number: 1049092-2021-00678
• Device Sequence Number: 20019840
• Product Code: EZD
• UDI-Device Identifier: 00815947020031
• UDI-Public: 00815947020031
• Combination Product (Y/N): N
• Initial Reporter State: AR
• PMA/510(K) Number: K132500
• 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): 12/13/2021

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: 10/28/2025
• Device Model Number: 510852
• Device Lot Number: 201118-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2020
• 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 Age: 51
• Patient Sex: Male