MAUDE Adverse Event Report: HOLLISTER INCORPORATED ONLI HYDROPHILIC IC CH14 40 CM

Catalog Number	82144-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of complaints for this product over the last 3 years completed and no adverse trends observed.Device history records (dhr) review completed and the records were found to be complete and accurate.The product ifu and risk assessment was reviewed for adequacy and no issues identified.Complaint samples requested but no samples available.A causal relationship between the use of the catheters and urinary tract infections could not be determined.
Event or Problem Description
It was reported that an end user who uses intermittent catheters developed a uti while using the hollister onli intermittent urinary catheter.He reported that his last uti was 2 years ago.He explained that in august, after using the onli catheters for 1 to 2 weeks and catheterizing up to 10 x day, he said started experiencing symptoms of a uti.He stated the symptoms he experienced were changes in the smell and color of his urine.He reported that he does not have any urinary tract pain sensation, however, he does have the ability to experience urinary frequency, which he experienced.He said he went to his doctor on august 20 and had a ua done.The doctor reportedly said he had a uti and prescribed him oral antibiotics (he does not know the name).He stated that the doctor did not indicate a cause of his uti.He denies having any difficulty using the catheters or catheterizing himself.He reported that he feels fine now.

• Brand Name: ONLI HYDROPHILIC IC CH14 40 CM
• Common Device Name: ONLI HYDROPHILIC IC CH14 40 CM
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 15536862
• Report Number: 9616668-2022-00004
• Device Sequence Number: 5997370
• Product Code: GBM
• UDI-Device Identifier: 00610075060665
• UDI-Public: 00610075060665
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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 Catalogue Number: 82144-30
• Device Lot Number: 2E283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male