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

Model Number	T12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Irritation (2076); Swelling (2091); Urinary Tract Infection (2120); Burning Sensation (2146)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient stated she is allergic to latex but did not experience the blistering she usually gets when exposed to latex.She did not need to use her epipen for the allergic reaction.Product is manufactured and labeled as not made with natural rubber latex.User's doctor said he was not sure what caused the reaction.
Event or Problem Description
Patient (user) tried a sample of a t12 catheter and after withdrawing it she felt a burning sensation and reported her urine had a strong smell so she thought she might be getting a urinary tract infection (uti).The next day the burning increased and the urethral area swelled and turned very red.Patient took benadryl for what she reported as an allergic reaction.On (b)(6) 2019 she saw her urologist and tested positive for a uti.She was prescribed an antibiotic and has fully recovered.Patient has changed to another manufacturer's catheter.

• Brand Name: TWIST CATHETER
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 8547119
• Report Number: 3005471919-2019-00030
• Device Sequence Number: 11198543
• Product Code: KOD
• UDI-Device Identifier: 10815947020380
• UDI-Public: (01)10815947020380(17)200328(10)170403-1(241)T12
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080881
• 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): 04/23/2019

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: 03/28/2020
• Device Model Number: T12
• Device Catalogue Number: T12
• Device Lot Number: 170403-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/24/2019
• 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: 52 YR
• Patient Weight: 88