MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CERAPLUS TAPE BORDER CUT TO FIT; OSTOMY BARRIER

Model Number 11203

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932); Rash (2033); Skin Tears (2516)

Event Date 03/17/2017

Event Type  Injury  

Manufacturer Narrative

The potential exists that this reported reaction to the barrier and/or tape may be associated with her underlying autoimmune condition and crohn's disease for which she takes prednisone and humira.There is no evidence the device malfunctioned.

Event Description

It was reported by the user that in (b)(6) of 2017, she experienced inflammation and rash with her hollister ostomy product.She changed to a new product, hollister new image ceraplus skin barrier with tape border.User also tried changes in adhesive remover and wipes and continued her keflex (for cellulitis) prescription.On (b)(6), 2017 she tried to change her barrier, which she indicated had failed three times that day.The skin tore and she could not stop the bleeding.She went to the er and then to a wound care facility.She received a seaweed dressing (calcium alginate) at the er although the bleeding had stopped on its own.She left the dressing in place for a week.They placed her in an alternate ostomy device.The user is also taking prednisone and humira for her crohn's disease which may have exacerbated her skin stripping.She is currently using a hollister tapeless product for her ostomy.

• Brand Name: NEW IMAGE CERAPLUS TAPE BORDER CUT TO FIT
• 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: 6461690
• MDR Text Key: 71825154
• Report Number: 1119193-2017-00009
• 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: 03/20/2017,04/05/2017

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: 11203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 03/20/2017
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/05/2017
• 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: 59 YR
• Patient Weight: 84