MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CUT-TO-FIT FLEXTEND SKIN BARRIER WITHOUT TAPE BORDER; OSTOMY BARRIER

Model Number 15603

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Anemia (1706); Irritation (1941); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

It appears that the user is in the wrong size appliance.Hollister has recommended that the user visit with her stoma nurse for proper evaluation and sizing.

Event Description

It was reported by the user that several months ago (she could not remember the month) she was admitted from the er to icu due to blood loss from her stoma.She received 2 units of blood.She said the blood loss was from the edges of the barrier rubbing her stoma.No additional medical treatment was given by the hospital for the bleeding stoma.The user states that she does not know the size of her stoma (she has never seen a stoma nurse) and she can not cut her current barrier large enough to accomodate her stoma.

• Brand Name: NEW IMAGE CUT-TO-FIT FLEXTEND SKIN BARRIER WITHOUT TAPE BORDER
• 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: 5704750
• MDR Text Key: 46765860
• Report Number: 1119193-2016-00013
• 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: 05/13/2016,06/08/2016

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: 15603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 05/13/2016
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 06/07/2016
• 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): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 113