MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE TRANSPARENT CUT-TO-FIT CONVEX BARRIER; OSTOMY

Model Number 14403

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

Patient Problems Skin Discoloration (2074); Skin Irritation (2076)

Event Date 04/14/2014

Event Type  Injury  

Event Description

It was reported that a patient received ostomy barriers that were not of the correct size.Through the secure start service, the clinician ordered one box of 14403 new image convex cut to fit skin barrier for the patient.The order form was unclear in that it indicated that both the flat and the convex barrier could be cut to fit over a size range of 13-44mm.The patient's stoma measured 41mm but the convex barrier can only be cut up to 38mm.The patient cut past the indicated limit and due to incorrect sizing the patient peristomal skin became red and excoriated.The patient was readmitted to hospital and iv antibiotics were administered.

Manufacturer Narrative

The order form has been further clarified.

• Brand Name: NEW IMAGE TRANSPARENT CUT-TO-FIT CONVEX BARRIER
• Type of Device: OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 999
• Manufacturer Contact: anne riba ; 2000 hollister dr; libertyville, IL 60048 ; 8476805625
• MDR Report Key: 3813646
• MDR Text Key: 16446891
• Report Number: 1119193-2014-00009
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/14/2014,05/15/2014

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: 14403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Home
• Date Report to Manufacturer: 04/14/2014
• Initial Date Manufacturer Received: 04/14/2014
• Initial Date FDA Received: 05/15/2014
• 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): Required Intervention
• Patient Age: 62 YR