MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER ONE PIECE DRAINABLE POUCHING SYSTEM; OSTOMY BARRIER

Model Number 8539

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Blood Loss (2597)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

There was no evidence of device malfunction; appears to need a larger size device.

Event Description

It was reported by the user that she went to the er in (b)(6) 2016 due to bleeding of her stoma.The bleeding appears to be from the edge of the barrier cutting into the stoma.No treatment was provided at the er but follow up with her surgeon resulted in cauterization in the area of bleeding.She changed from her 1.5" barrier opening to a 1.75" barrier opening.The bleeding began again in (b)(6) 2016 but she did not seek treatment.She is changing to a barrier with a larger size opening to prevent the rubbing.

• Brand Name: PREMIER ONE PIECE DRAINABLE POUCHING SYSTEM
• Type of Device: OSTOMY BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: anne riba ; 2000 hollister dr; libertyville, IL 60048 ; 8476805625
• MDR Report Key: 5808434
• MDR Text Key: 49975490
• Report Number: 1119193-2016-00016
• 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: Patient
• Type of Report: Initial
• Report Date: 06/20/2016,07/20/2016

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 Model Number: 8539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 06/20/2016
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/20/2016
• 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): Other
• Patient Age: 74 YR
• Patient Weight: 86