MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS PKT HYDROPHILIC IC CH14 40CM; VAPRO PLUS POCKET

Catalog Number	71144
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No samples or photos available to investigate.Two lot numbers possibly related to this report were provided by the account.Hollister verified that these lots of products were sterilized in accordance with the dmr.In addition, a review of the dhr found the records to be complete and accurate.
Event or Problem Description
It was reported that the end user was hospitalized for urosepsis.It was reported that the end user's wife, who catheterizes the patient, stated that the collection bags were leaking from a potential hole or edge seal failure.The user's wife also reported that the catheter's no touch sleeve pulls like chewing gum, tears, and leaks.There was no allegation of contamination.It was further reported by the wife that there was nothing wrong with the catheters themselves and the urine was able to be drained as intended.The treatment reported by the wife was with high doses of antibiotics and then discharged from the hospital.

• Brand Name: VAPRO PLUS PKT HYDROPHILIC IC CH14 40CM
• Common Device Name: VAPRO PLUS POCKET
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, ie ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8476802170
• MDR Report Key: 17378813
• Report Number: 9616668-2023-00003
• Device Sequence Number: 14970628
• Product Code: GBM
• UDI-Device Identifier: 00610075065332
• UDI-Public: 00610075065332
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193148
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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: 71144
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male