MAUDE Adverse Event Report: HOLLISTER INCORPORATED 1-PIECE DRAINABLE OSTOMY POUCH, FLEXTEND; COLLECTOR, OSTOMY

Model Number 8531

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

The entire box was defective.The item is supposed to roll up and velcro to another spot to hold.One side of the velcro is not adhered and falls off causing the item to not do the job its supposed to and would potentially leak stool.Defective adherent velcro.

• Brand Name: 1-PIECE DRAINABLE OSTOMY POUCH, FLEXTEND
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr.; libertyville IL 60048
• MDR Report Key: 16102300
• MDR Text Key: 306714223
• Report Number: 16102300
• 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: 12/14/2022

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: Health Professional
• Device Model Number: 8531
• Device Catalogue Number: 8531
• Device Lot Number: 21212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1