MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CERAPLUS BARRIER WITH TAPE BORDER; OSTOMY POUCHING SYSTEM

Model Number 11203

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Date 08/28/2017

Event Type  Injury  

Event Description

It was reported by the user that she started physical therapy which included stretching her abdominal area.The new image ostomy product tape border did not stretch resulting in skin damage consisting of little skin tears.She was experiencing big pimples with yellow crust and red skin under the tape portion of the barrier.Her dermatologist prescribed betamethasone spray for the skin which is helping.She believes her physical therapy and consequent stretching of the skin on her abdomen along with a sensitivity to adhesives caused the issue under the tape.

• Brand Name: NEW IMAGE CERAPLUS BARRIER WITH TAPE BORDER
• 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: 6866681
• MDR Text Key: 86253064
• Report Number: 1119193-2017-00032
• 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: 08/28/2017,09/14/2017

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
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Report to Manufacturer: 08/28/2017
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/14/2017
• 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): Other
• Patient Age: 69 YR
• Patient Weight: 79