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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED KARAYA 5 DRAINABLE MINIPOUCH WITH TAPE BORDER OSTOMY BARRIER

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HOLLISTER INCORPORATED KARAYA 5 DRAINABLE MINIPOUCH WITH TAPE BORDER OSTOMY BARRIER Back to Search Results
Model Number 3233
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hemorrhage/Bleeding (1888); Skin Irritation (2076); Tissue Damage (2104); Reaction (2414)
Event Date 10/25/2016
Event Type  Injury  
Manufacturer Narrative
Biocompatibility testing has been performed in accordance with is0 10993 and materials were found to be non-sensitizers. User has had her stoma for 35 years and has always used this product. The dhr review showed it was complete and accurate. No root cause could be determined at this time.
 
Event Description
It was reported by the user that on approximately (b)(6) 2016 she started noticing skin irritation under the tape portion of the barrier. It continued to worsen although she tried stoma powder and calamine lotion. The skin was bleeding, weeping, with red, prickly marks and 2 places had solid raised ulcerated areas. She saw her dermatologist who told her she was having a reaction and prescribed clobetasol proprionate 0. 05% steroid gel. After two days of using the gel she noticed improvement in the area of irritation. She has been provided with new product and skin protectant gel for her to try.
 
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Brand NameKARAYA 5 DRAINABLE MINIPOUCH WITH TAPE BORDER
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 Key6170676
MDR Text Key62267023
Report Number1119193-2016-00026
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 Patient
Type of Report Initial
Report Date 11/15/2016,12/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3233
Device Lot Number5L022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Home
Date Report to Manufacturer11/15/2016
Date Manufacturer Received11/15/2016
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 Treatment Data
Date Received: 12/13/2016 Patient Sequence Number: 1
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