MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER SOFT CONVEX CERAPLUS UROSTOMY POUCH CUT-TO-FIT

Catalog Number 84134

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

Patient Problem Urinary Tract Infection (2120)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

A review of this sku over the last 3 years show no other reports of suction or urine backup.Device history review could not be conducted because the lot number was not provided.The affected pouches were not returned so sample evaluation is not possible.End user's weight is not known so an estimation was used.The root cause of the suction not allowing the urine to flow into the tubing could not be determined.Hollister is sending a sample of a different type of pouch to see if this works better for the end user.It is not known if the pouch suction caused or contributed to the reported infection.

Event Description

An end user reported that his hollister urostomy pouch developed a suction after 2 - 3 days of use and didn't allow urine to flow down into the tubing.He then experienced abdominal discomfort and was diagnosed with a urinary tract infection requiring antibiotics.The end user believes that the suction in the urostomy pouch caused a backflow of urine into his kidneys resulting in this infection.

• Brand Name: PREMIER SOFT CONVEX CERAPLUS UROSTOMY POUCH CUT-TO-FIT
• Type of Device: PREMIER SOFT CONVEX CERAPLUS UROSTOMY POUCH CUT-TO-FIT
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, rehins ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 11265431
• MDR Text Key: 229837225
• Report Number: 9616668-2021-00002
• Device Sequence Number: 1
• Product Code: EXB
• 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: 02/02/2021

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 84134
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/02/2021
• 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: 76 YR
• Patient Weight: 68