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

Catalog Number 82144-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 08/20/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 301103836
• Report Number: 9616668-2022-00004
• Device Sequence Number: 1
• Product Code: GBM
• UDI-Device Identifier: 00610075060665
• UDI-Public: 00610075060665
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 82144-30
• Device Lot Number: 2E283
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male