MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE TRANSPARENT SKIN BARRIER WITH ADHESIVE BORDER; OSTOMY BARRIER

Model Number 14603

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Rash (2033)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

The customer reports what appears to be an allergic reaction to barrier but feels that the product has been changed.A one year review of the product file shows no material changes in the last year.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 has been using a hollister new image product for close to seven years.She began experiencing inflammation and a rash under the barrier for which she saw a dermatologist who suggested steroid cream.She is currently taking humira and prednisone for treatment of crohn's disease.She was also taking keflex for cellulitis in her back and her gi doctor instructed her to continue to take it for the irritation under the barrier.Hollister has provided the patient with a different product to try.

• Brand Name: NEW IMAGE TRANSPARENT SKIN BARRIER WITH ADHESIVE BORDER
• 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: 6461170
• MDR Text Key: 71753279
• Report Number: 1119193-2017-00008
• 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: 03/06/2017,04/05/2017

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: 14603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 03/06/2017
• Initial Date Manufacturer Received: 03/06/2017
• 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): Other
• Patient Age: 59 YR
• Patient Weight: 84