VaPro Pocket
Received Jul 27, 2026 · Event occurred Jul 13, 2026
Report 9616668-2026-00006 · MDR key 50015473
Device
Generic name
Notouch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Ti
Manufacturer
Hollister IncorporatedModel number
70144Lot number
6B103
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Urinary Tract Infection
Narrative
Description of Event or Problem
It was reported that while using a Hollister VaPro Pocket Intermittent Catheter, the patient experienced difficulty inserting the catheter due to significant resistance, pain, irritation and possible injury resulting in discontinuation of catheterization. It was also reported that some catheters appeared bent, damaged, or broken within the packaging. It was also reported that the end user experienced UTIs. No further details regarding the reported issues were provided.
Additional Manufacturer Narrative
A Device History Record (DHR) and sterilization record review were completed and no adverse trends identified. All records reviewed were found to be complete and accurate, there were no adverse trends observed. Based on the information available at this time, a causal relationship between the device and the reported event has not been established. No root cause has been determined.