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

Model Number 14905

Device Problems Device Emits Odor (1425); Patient-Device Incompatibility (2682)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

The customer reports a "strong chemical odor" from the new image barrier.Analytical testing was performed on the returned product as well as from product that was pulled from stock.There was no remarkable difference noted between the tested products.No residue of an unexpected nature was observed.Note: the original complaint was not deemed to be a fileable event.Upon receiving additional information on march 20, 2017 the complaint was reopened and further evaluated.Following the completion of the investigation it was determined to be a mdr.

Event Description

It was reported that the patient developed a rash using hollister new image flextend barrier.The treating nurse diagnosed it as an allergic reaction due to chemical issue or chemical burn.The patient had noted a "strong chemical smell" when opening the barrier packaging.Patient was treated with triamcinolone cream and switched to a different product.Product evaluation and dhr review for lot 6j142 determined that there was nothing remarkably different observed in this product lot.

• Brand Name: NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE
• 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: 6493521
• MDR Text Key: 72837548
• Report Number: 1119193-2017-00012
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/19/2017,04/14/2017

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: 14905
• Device Lot Number: 6J142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Home
• Date Report to Manufacturer: 02/19/2017
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 86 YR
• Patient Weight: 54