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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED KARAYA 5 ONE PIECE PRE-SIZED DRAINABLE OSTOMY POUCH

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HOLLISTER INCORPORATED KARAYA 5 ONE PIECE PRE-SIZED DRAINABLE OSTOMY POUCH Back to Search Results
Catalog Number 3223
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
Trend data reviewed and this was identified as an isolated incident. Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review was not possible because lot number not provided. Sample review not possible because no sample available. The root cause of the recurring yeast infections cannot be determined.
 
Event Description
It was reported that an end user has been experiencing recurring yeast infections around her ileostomy stoma since 2016. She says she gets the infections when she swims or sweats. She has a standing order for nystatin powder which she uses with stoma powder and it clears it up. She has been put in touch with hollister customer service to see if there is a product that better meets her needs.
 
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Brand NameKARAYA 5 ONE PIECE PRE-SIZED DRAINABLE OSTOMY POUCH
Type of DeviceKARAYA 5 ONE PIECE PRE-SIZED DRAINABLE OSTOMY POUCH
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister drive
libertyville, il
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft, va
Manufacturer Contact
linda wisowaty
2000 hollister drive
libertyville., 
6802170
MDR Report Key10333346
MDR Text Key200636484
Report Number1119193-2020-00018
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number3223
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/28/2020 Patient Sequence Number: 1
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