MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER SOFTFLEX; COLLECTOR, OSTOMY

Model Number 82500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2019

Event Type  malfunction  

Event Description

Multiple urostomy bags (premier one-piece urostomy pouch-flat extend barrier, tape) found to have adhesive that does not stick.

• Brand Name: PREMIER SOFTFLEX
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr.; libertyville IL 60048
• MDR Report Key: 8859954
• MDR Text Key: 153245522
• Report Number: 8859954
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 82500
• Device Catalogue Number: 82500
• Device Lot Number: 242261
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2019
• Date Report to Manufacturer: 08/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1