MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND SKIN BARRIER; OSTOMY BARRIER

Model Number 16107

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Skin Irritation (2076)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

The customer reports what appears to be a sensitization to the product.Biocompatibility testing in accordance with iso 10993 has been successfully completed on the barrier material and there was no evidence of sensitization.

Event Description

It was reported by the user that she had been using a hollister new image product with tape for approximately 18 months since her stoma surgery.She began experiencing skin irritation which was mainly under the tape.She switched products and for the last seven months she has been using a new image non tape product.The product was not adhering well and she was changing the product daily, making the irritation worse.She went to her doctor and was prescribed steroidal cream and has switched to a new barrier.After the second day now she feels the irritation may be improving.

• Brand Name: NEW IMAGE FLEXTEND SKIN BARRIER
• 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: 6491381
• MDR Text Key: 72778430
• Report Number: 1119193-2017-00011
• 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: 03/16/2017,04/14/2017

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: 16107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 03/16/2017
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/13/2017
• 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: 41 YR
• Patient Weight: 57