MAUDE Adverse Event Report: CURE MEDICAL LLC CURE CATHETER; URINARY CATHETER

Model Number	M14U
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Sharp Edges (4013)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Hematuria (2558)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said the m14u catheter is too stiff for him to insert without causing bleeding.He did not notice any defect when examining the catheters but said he felt they were too stiff and sometimes nicked him.He discarded the one that may have nicked him.He tried the m14u but it was not as bendable as the other catheter brand that he was used to but can no longer acquire.
Event or Problem Description
Intermittent catheter patient (user) reported that m14u catheters were causing him to bleed and have urinary tract infections (uti).During follow-up, the patient reported he recovered completely after taking the full course of antibiotics prescribed by his doctor.

• Brand Name: CURE CATHETER
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; neport beach, ca 92663, us, ca
• MDR Report Key: 9941627
• Report Number: 3005471919-2020-00013
• Device Sequence Number: 11700345
• Product Code: EZD
• UDI-Device Identifier: 00815947020123
• UDI-Public: (01)00815947020123(17)240428(10)190504-5(241)M14U
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/28/2024
• Device Model Number: M14U
• Device Catalogue Number: M14U
• Device Lot Number: 190504-5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Weight: 91