MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CONVEX FLEXTEND 1" BARRIER OPENING; OSTOMY

Model Number 15904

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/01/2015

Event Type  Injury  

Event Description

It was reported by the user that she had intermittent bleeding from her stoma which has occurred over a two year period and was caused by the ostomy barrier cutting into her stoma.She can see the area that bleeds; it is about 3/4" long on the right side of the stoma.It would bleed on and off filling her night bags with blood and massive clots.It stops bleeding when she would apply pressure.She received her first blood transfusion about a year ago.She sought medical treatment for the most recent bleeding incident.She was admitted to the hospital in (b)(6) of 2015 and received 6 units of blood.The hospital performed a pelvic ct scan and mri and did not find anything wrong.The hospital placed her in a flat ostomy barrier instead of her convex.Upon discharge from the hospital she saw a wocn who stated that the patient was using a barrier with too small of an opening.She was in a 1" barrier and she should have been in a 1.5" barrier.She has had one more recent episode of bleeding when she ran out of her 1.5" barriers and went back to the 1" barrier.She is not on blood thinners.

Manufacturer Narrative

Instructed user to contact health care professional if any further bleeding.

• Brand Name: NEW IMAGE CONVEX FLEXTEND 1" BARRIER OPENING
• 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: 4878086
• MDR Text Key: 20448082
• Report Number: 1119193-2015-00007
• 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: 06/02/2014,06/30/2015

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: 15904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 06/02/2014
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/30/2015
• 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: 61 YR
• Patient Weight: 116