MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS PKT HYDROPHILIC IC CH12 40CM

Catalog Number	71124-25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dhr (device history records) review is not possible because lot number not provided.Sample review not possible because sample not saved.Trend review conducted and no adverse trends were observed.No report of hematuria for this product over the past 3 years.Hollister cannot confirm a product problem.Root cause for this report cannot be determined.
Event or Problem Description
A hospital reported that a hollister vapro plus pocket intermittent urinary catheter caught on removal after bladder drainage and required more force than normal to remove; the coating was sticky and dry, which reportedly caused the patient to experience hematuria.They also reported that the patient was unwell for 5 days after the report and iv antibiotics were prescribed for the hematuria.The hospital further reported that there were no long term patient issues or prescriptions from the incident.

• Brand Name: VAPRO PLUS PKT HYDROPHILIC IC CH12 40CM
• Common Device Name: VAPRO PLUS PKT 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: 13900418
• Report Number: 9616668-2022-00002
• Device Sequence Number: 11911150
• Product Code: GBM
• UDI-Device Identifier: 00610075065318
• UDI-Public: 00610075065318
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K193148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2022

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: 71124-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown