MAUDE Adverse Event Report: HOLLISTER INCORPORATED ONLI HYDROPHILIC IC CH16 40CM; ONLI HYDROPHILIC INTERMITTENT CATHETER

Catalog Number	82164-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of complaints for this product over the last 3 years show no other reports of urinary tract infections associated with the use of these catheters.The lot number is not known and multiple lots of products were used during the course of 2 years.The product ifu and risk assessment was reviewed for adequacy and no issues identified.A causal relationship between the use of the catheters and urinary tract infections could not be determined.
Event or Problem Description
End user of the hollister onli intermittent urinary catheter has reported that he has experienced 4 utis over the last 2 years of using these catheters.His last uti was in the beginning of december and he was prescribed cipro and nitrofurantoin.He catheterizes 4x/day and doesn't feel like he is fully emptying his bladder.He states he uses sterile technique and does not reuse the catheters.His doctor has suggested he increase the frequency of cath'ing from 4 to 6x/day.He denies any device malfunction.The doctors could not determine the root cause of his utis.

• Brand Name: ONLI HYDROPHILIC IC CH16 40CM
• Common Device Name: ONLI HYDROPHILIC INTERMITTENT CATHETER
• 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: 13224269
• Report Number: 9616668-2022-00001
• Device Sequence Number: 17168867
• Product Code: GBM
• UDI-Device Identifier: 00610075060672
• UDI-Public: 00610075060672
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K163179
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2022

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: 82164-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/11/2022
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 59 KG