MAUDE Adverse Event Report: HOLLISTER INCORPORATED ONLI HYDROPHILIC IC CH12 40CM

Catalog Number	82124-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an end user who had been using the onli hydrophilic catheters for 3 years, developed a uti.It was reported that the patient was catherizing for urine via a mitrofanoff stoma and klebsiella was identified via urine culture.It was further reported that the end user was placed on oraxim and orelox antibiotics for 10 days to treat the infection.
Additional Manufacturer Narrative
The product ifu states that this intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from their bladder.In this case, the customer reports that they use the catheters to drain urine thru the patient's mitrofanoff stoma.The mitrofanoff procedure creates a small tunnel from the bladder to the outside of the body.Since hollister's indication for use is for device usage through a urethra, this reported usage is considered off-label.Product sample not provided so sample review was not possible.Lot number is not known so dhr review is not possible.The root cause of the reported uti is not known.

• Brand Name: ONLI HYDROPHILIC IC CH12 40CM
• Common Device Name: ONLI HYDROPHILIC IC CH12 40CM
• 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: 15925397
• Report Number: 9616668-2022-00006
• Device Sequence Number: 6317750
• Product Code: GBM
• UDI-Device Identifier: 00610075060658
• UDI-Public: 00610075060658
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

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: 82124-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 12/06/2022
• 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: 10 YR
• Patient Sex: Female
• Patient Weight: 32 KG