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

Model Number 14602

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Reaction (2414)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

The customer reports what was diagnosed as an allergic reaction to the tape/ barrier.Biocompatibility testing in accordance with iso 10993 has been successfully completed and there was no evidence of sensitization.

Event Description

It was reported by the user that she has been using the hollister new image sku 14602 product for four years.She began to experience a reaction around the tape area approximately 6 months ago.She was treated with an otc topical fungal cream followed by prescription oral antifungal medication.The rash did not clear up and was causing her to change her appliance 2-3 times per day.She has been diagnosed with an allergic reaction and is changing to a different product.

• Brand Name: NEW IMAGE FLEXTEND SKIN BARRIER WITH ADHESIVE TAPE 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: 6535379
• MDR Text Key: 74124129
• Report Number: 1119193-2017-00017
• 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: 04/06/2017,05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 04/06/2017
• Date Manufacturer Received: 04/06/2017
• 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: 58 YR
• Patient Weight: 74