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U.S. Department of Health and Human Services

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

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HOLLISTER INCORPORATED NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE OSTOMY BARRIER Back to Search Results
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.
 
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Brand NameNEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE
Type of DeviceOSTOMY 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 Key6493521
MDR Text Key72837548
Report Number1119193-2017-00012
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
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
Date FDA Received04/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number14905
Device Lot Number6J142
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Home
Date Report to Manufacturer02/19/2017
Date Manufacturer Received02/17/2017
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 Treatment Data
Date Received: 04/14/2017 Patient Sequence Number: 1
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