MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CERAPLUS CONVEX WITH CUT TO FIT BARRIER; OSTOMY POUCHING SYSTEM

Model Number 15302

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation (2443)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

User has had skin reactions to multiple devices/brands.There was no evidence of a device malfunction.There is no trend observed for this sku and complaint type.

Event Description

It was reported that the end user developed irritation, itching and redness around the stoma under the barrier.User went to the doctor and (b)(6) but the cause was unable to be determined.Steroid spray was prescribed.The user applies the spray under the barrier every time he changes the barrier.

• Brand Name: NEW IMAGE CERAPLUS CONVEX WITH CUT TO FIT BARRIER
• Type of Device: OSTOMY POUCHING SYSTEM
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60068
• 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: 7409178
• MDR Text Key: 104803386
• Report Number: 1119193-2018-00013
• 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: 03/12/2018,04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 15302
• Device Catalogue Number: 15302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Report to Manufacturer: 03/12/2018
• Date Manufacturer Received: 03/12/2018
• 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: 82