MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER FLEXTEND DRAINABLE POUCH WITH VIEWING OPTION AND TAPE BORDER

Catalog Number 8371

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Blood Loss (2597)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Although requested, the end user never returned the ostomy appliance sample for evaluation.Without the benefit of the sample, a device evaluation is not possible.The dhr was reviewed and no problems identified.A trend analysis was conducted and no adverse trends for this failure observed.The root cause of the reported stoma laceration cannot be determined.It has not been concluded that the ostomy pouch caused or contributed to this reported event.

Event Description

It was reported that an end user's stoma started bleeding from a cut in his stoma.He saw that the ostomy pouch filter had fallen into the pouch.He feels the filter cut his stoma.He went to the emergency room after applying pressure did not stop the bleeding.The emergency room used silver nitrate to stop the bleeding.They determined that he needed 1 unit of blood and was hospitalized for 24 hours.The stoma has now healed.

• Brand Name: PREMIER FLEXTEND DRAINABLE POUCH WITH VIEWING OPTION AND TAPE BORDER
• Type of Device: PREMIER FLEXTEND DRAINABLE POUCH WITH VIEWING OPTION AND TAPE BORDER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60046-3781 ; 8476802170
• MDR Report Key: 8518470
• MDR Text Key: 142079173
• Report Number: 1119193-2019-00010
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8371
• Device Lot Number: 7I062
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2017
• 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: 49 YR
• Patient Weight: 76