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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 3228
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pressure Sores (2326)
Event Date 06/25/2020
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 peristomal injury could not be confirmed.
 
Event Description
It was reported that an end user has been using this hollister ostomy appliance for 45 years. Over the last 6 weeks, he has developed a peristomal wound located above his stoma. The wound is causing him to have to change is ostomy appliance between 1 to 5 times a day. His wocn nurse stated that the end user has gained weight, has a belly and is using the wrong product. The wocn thinks it may be a pressure sore from the appliance and has been treating him with numerous wound care products in order to help resolve the wound. Hollister is sending him samples of flat ostomy barrier appliances per the wocn's request.
 
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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 Key10391369
MDR Text Key202517607
Report Number1119193-2020-00022
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,health professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number3228
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
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: 08/11/2020 Patient Sequence Number: 1
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